Total No. of Questions : 5] SEAT No.

:
PB4649 [Total No. of Pages : 2
[6282]-111
First Year [Link].
MPAT 101T : MODERN PHARMACEUTICAL ANALYTICAL
TECHNIQUES PHARMACEUTICAL CHEMISTRY
(Common Subjects for all Specialization 2019 Credit Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) Give a comparative account on instrumentation of IR spectrometer and

UV-Visible spectrometer. [15]
OR
Describe quantum numbers and their role in NMR, relaxation processes, solvents
used in NMR and nuclear magnetic double resonance.

Q2) Attempt any Two: [15]

a) Elucidate the structure of organic compound from the following data
Molecular Formula: C7H7ON
IR: 3490 cm–1, 3405 cm–1, 3020 cm–1, 2850 cm–1, 2720 cm–1, 1470 cm–1,
830 cm–1
PMR: 9.3 (s, 1H), 7.0 (d, 2H), 7.4 (d, 2H), 4.2 (s, 2H)
b) Describe various X-ray diffraction methods.
c) Elaborate on the instrumentation of Thermogravimetric analysis.
d) Explain different modes of HPLC based on separation principle. Add a
note on stationary phases used in HPLC.
P.T.O.
Q3) Attempt any Three. [15]

a) Write a note on Paper Electrophoresis.

b) Explain the effect of experimental parameters in Differential Scanning

Calorimetry.

c) Write Principle, advantages and applications of Differential Thermal

Analysis.

d) Describe Instrumentation of Ion exchange chromatography.

e) Explain fundamental band, overtones, combination bands and Fermi

resonance in IR Spectroscopy.

Q4) Give a comparative account on various types of ionization techniques used in

Mass Spectrometry. [15]

OR

Explain the Principle, steps and instrumentation of HPTLC.

Q5) Write a short note on (Any three): [15]

a) Instrumentation of Atomic absorption Spectroscopy.

b) Principle of X-ray Crystallography and Bragg’s law.

c) Pharmaceutical applications of Differential Scanning Calorimetry.

d) Detectors used in fluorimetry.

e) Isoelectric focusing.



[6282]-111 2
Total No. of Questions : 5] SEAT No. :
PB4650 [Total No. of Pages : 2
[6282]-112
First Year [Link]
MRA -101T : GOOD REGULATORY PRACTICES
(Credit 2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Long answer questions (Any 1) : [1×15=15]

a) Explain in details about cGMP for Finished Pharmaceuticals.
b) Give detail account of ICH Q1 A guideline.

Q2) Medium length answers (Any 2) : [2×7½=15]

a) Give the rules of classification under Medical device and IVDs Global
Harmonization Task Force(GHTF) Guidance does.
b) Explain principles of GALP regulations and GALP requirements.
c) Write in brief about subpart D (equipment) details of 2l CFR Part 11.
d) Explain future of GLP regulations.

Q3) Short Answers (Any 3) : [3×5=15]

a) Write a note on software evaluation checklist.
b) What do you mean by GDP ? Give the principle of GDP for GLP.
c) Give details about laboratory management and personal details under
GALP.
d) Write a note on cleaning validation.
e) Give various types of validation along with validation master plan.

P.T.O.
Q4) Long answer questions (Any 1) : [1×15=15]

a) Explain in details about Article 6 to Article 14 under Directive 91/356/EEC.

b) Describe about USFDA GLP Regulations (Subpart A to Subpart K)

Q5) Short notes (Any 3) : [3×5=15]

a) Give the importance of GDP along with general requirements of GDP.

b) Validation of HAVC.

c) ICH guidelines to establish quality, safety of drug substance.

d) General & documentation requirements in QMS under Schedule M-III.

e) Explain in detail types of qualification.



[6282]-112 2
Total No. of Questions : 5] SEAT No. :
PB4651 [Total No. of Pages : 2
[6282]-113
First Year [Link]
PHARMACEUTICAL BIOTECHNOLOGY
MPB-102T : Microbial and Cellular Biology
(Credit 2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) Explain the parameters require for microbial growth. How will you preserve
the microbial cultures. [15]
OR
Explain the structure, morphology, cultural, physiological and reproductive
features of fungal cell.

Q2) Answer the following (Any two) [15]

a) What is plasmids? Explain the gene mapping of plasmids.
b) Explain different types of animal cell cultures.
c) Explain mechanism of action of antimicrobial agents and possible sites
of chemotherapy.
d) Write the basic aspects of cell regulation, bioenergetics and fuelling
reactions of anaerobics.

Q3) Write a note on (Any three) [15]

a) Cyto toxicity - Invitro screening technique.
b) RNA splicing and editing.
c) Features of pathogenic viruses.
d) Cell cycle and apoptosis.
e) Nuclear receptors.

P.T.O.
Q4) What is embryonic germ cell? Explain in detail stem cells and its applications.[15]

OR

Explain types of mutants and applications of mutagenesis in strain improvement.

Q5) Answer the following (Any three) [15]

a) Industrially important microorganisms.

b) In-vitro fertilization.

c) Therapy for bacterial infections.

d) Transcriptional control and translational control.

e) Phage genetics.



[6282]-113 2
Total No. of Questions : 5] SEAT No. :

PB-4652 [Total No. of Pages : 2

[6282]-114
M. Pharmacy (Pharmaceutical Chemistry)
MPC 102 T : ADVANCED ORGANIC CHEMISTRY - I
(2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Neat labelled diagrams must be drawn wherever necessary.

Q1) What is retrosynthesis & synthon approach? Write about functional group
interconvertion and addition (FGI and FGA). [15]

OR

Explain reaction mechanism and applications of Dieckmann reaction. Mannich

reaction and Sandmeyer reaction.

Q2) Attempt any Two. [15]

a) Write synthesis of metronidazole and promazine.

b) Explain the preparation, salient features of Aluminium isopropoxide and

N-bromosuccinimide. Explain their applications in organic synthesis.

c) Discuss about stereochemistry and factors affecting nucleophile

unimolecular and bimolecular substitution reactions.

d) Explain the detailed mechanism and reactions with synthetic applications

of Mitsunobu reaction and Doebner-Miller reaction.

P.T.O.
Q3) Attempt any three : [15]

a) Write mechanism and synthetic applications of ullmann coupling reaction.

b) Discribe about method of formation, stability and synthetic applications

of carbocations and carbonions as organic reaction intermediates.
c) Discuss about rearrangement reactions.
d) Explain about mechanism and synthetic importance of Biginelli reaction.
e) Explain bimolecular elimination reaction with example.

Q4) Explain protection for hydroxy & carboxyl groups with suitable example.[15]

OR

Describe mechanism and application of Knorr Pyrozole synthesis and Pinner

pyrimidine synthesis with suitable example of drugs.

Q5) Write short note on (Any Three) : [15]

a) Write a not on free radicals.

b) Ugi reactions and its synthetic applications.

c) Synthetic applications of Wilkinson and witting reagent.

d) Ozonolysis.

e) Hoffman & Saytzeff’s rules of elimination reaction.



[6282]-114 2
Total No. of Questions : 5] SEAT No. :

PB-4653 [Total No. of Pages : 2

[6282]-115
First Year M. Pharmacy
MPG 102T : ADVANCED PHARMACOGNOSY - I
(2019 Pattern) (Semester - I) (Credit System)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) Answer all questions.
2) Figures to the right indicate full marks.
3) Neat diagrams must be drawn wherever necessary.

Q1) Answer the following (Solve any one) : [15]

a) Explain in detail about recent advances in research in marine drugs.
b) Elaborate detail account of Current Good Agricultural practices.

Q2) Answer the following (Solve any two) : [15]

a) Write a note on digestive enzymes.
b) Describe Marine toxins.
c) Write short note on Formulation and standardisation of Nutraceuticals.
d) Comment on Ex-situ conservation of medicinal plants.

Q3) Write in short (Solve any three) : [15]

a) Classification of Functional food with suitable examples.
b) Write note on Current trends and future scope on Nutraceuticals.
c) Medicinal and Health benefits of Taxol.
d) Comment on Regulatory aspects of Nütraceuticals.
e) Discuss Current Good Collection practices.

P.T.O.
Q4) Answer the questions (Solve any one) : [15]

a) Discuss in detail about the occurrence, isolation and characteristic feature

of Rutin and Hesperidin.

b) Elaborate AYUSH guidelines for safety monitoring of natural medicines.

Q5) Short note (Solve any three) : [15]

a) Isolation of Ellagic acid.

b) Bio drug-food interaction with suitable examples.

c) Chemical nature, Medical benefits and health benefits of Spirulina.

d) Medicinal uses and health benefits herbal tea.

e) Occurrence and isolation of Vascine.



[6282]-115 2
Total No. of Questions : 5] SEAT No. :

PB-4654 [Total No. of Pages : 2

[6282]-116
[Link]
MPH - 102T : DRUG DELIVERY SYSTEMS
(2019 Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) Answer any one : [15]

a) Compare sustained released delivery systems with conventional delivery

systems. Discuss in detail prerequisites of drug candidate for development
of SR formulations.

b) Explain the need for Gastro-retentive drug delivery system with detailed
account of various formulation principles/approaches used.

Q2) Answer any two of four each question carries 7½ marks :

[2 × 7½ = 15]

a) Give the classification, properties and applications of polymers.

b) What are the key components and designs of a transdermal patch and
their respective functions?

c) Explain iontophoresis and sonophoresis for delivery ocular drug?

d) Discuss in detail about barriers for protein delivery.

P.T.O.
Q3) Answer any 3 out of 5 each question carries 5 marks : [3 × 5 = 15]

a) Explain in brief about customized drug delivery systems.

b) Explain in brief about in-situ gelling mechanisms and applications.

c) Explain in brief about enzyme activated drug delivery systems.

d) Describe Robinson Eriksen equation for calculation of SR doses.

e) Elaborate upon role of Ion exchange resins as controlled drug delivery

carriers.

Q4) Answer 1 out of 2 : [15]

a) Elaborate the challenges associated with topical ocular drug delivery,

and ways to overcome them.

b) Discuss in detail about formulation and evaluation of various buccal

formulations.

Q5) Write note on any 3 out of 5, each question carries 5 marks :

[3 × 5 = 15]

a) Evaluation of polymers

b) Reservoir Vs Matrix Sustained release DDS.

c) Franz diffusion cell based permeation study for evaluation of TDDS.

d) Osmotic Tablet

e) Classify polymers with examples and their pharmaceutical applications



[6282]-116 2
Total No. of Questions : 5] SEAT No. :

PB-4655 [Total No. of Pages : 2

[6282]-117
[Link]
MPL - 102T : ADVANCED PHARMACOLOGY - I
(2019 Credit Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw neat labeled diagrams wherever necessary.

Q1) Answer the following (one out of two) : [15]

a) Classify Anticonvulsants. Write pharmacotherapy of drugs used in Grand

mal Seizures.

b) Write a note on Opioid Autacoids. Discuss in brief Opioid agonists and

antagonists with respect to their therapeutic applications

Q2) Solve any 2 out of 4 : [15]

a) Explain the role of Angiotensin receptor inhibitors in the management of

hypertension.

b) Write a note G protein coupled receptors with secondary messengers

involved in signal transduction.

c) Classify Antipsychotics. Describe pharmacology of second generation

antipsychotics.

d) Discuss the pharmacological actions of 5HT

P.T.O.
Q3) Write short note on (any 3 out of 5) : [15]

a) Pharmacology of Imipramine

b) Atropine poisoning and its management.

c) Coagulants

d) Pathological role of prostaglandins.

e) COMT inhibitors

Q4) Answer the following (1 out of 2) : [15]

a) Discuss in brief the effects of acetylcholine on muscarinic as well as

nicotinic receptor subtypes.

b) Define hyperlipidemia classify anti-hyperlipidemic drugs and explain in

brief the pharmacology of statins.

Q5) Write short note on (any 3 out of 5) : [15]

a) Selective COX-II Inhibitors

b) Fibrinolytics

c) Barbiturates

d) Drug plasma concentration Vs Effect relationship

e) Phosphodiesterase inhibitors in heart failure.



[6282]-117 2
Total No. of Questions : 5] SEAT No. :

PB-4656 [Total No. of Pages : 2

[6282]-118
[Link] (Pharmaceutical Quality Assurance)
MQA - 102T : QUALITY MANAGEMENT SYSTEMS
(2019 Credit Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.

Q1) Long answer questions (Solve 1 out of 2) : [1 × 15 = 15]

a) Elaborate on Quality as a Strategic Decision and quality management.
[15]
b) Explain Total Quality Management in detail. [15]

Q2) Medium Length answers (Solve 2 out of 4) : [2 × 7½ = 15]

a) Explain importance of Corrective and Preventive actions (CAPA) in
pharmaceutical industry. [7½]
b) Explain concept of Vendor Qualification. [7½]
c) Elaborate on NABL certification and accreditation. [7½]
d) Describe elements of a PQS as per ICH Q10. [7½]

Q3) Short answer questions (Solve 3 out of 5) : [3 × 5 = 15]

a) Give importance of statistical Process control (SPC). [5]
b) Explain benchmarking Process. [5]
c) Explain principles of six sigma. [5]
d) Brief on ISO guidelines. [5]
e) Explain WHO - GMP requirements. [5]

P.T.O.
Q4) Long answer questions (Solve 1 out of 2) : [1 × 15 = 15]

a) Explain in detail cost of quality. [15]

b) Explain ICH Q9 in detail. [15]

Q5) Short notes (Solve 3 out of 5) : [3 × 5 = 15]

a) Handling Out of Trend results. [5]

b) Annual Product Reviews. [5]

c) Statistical Control Charts. [5]

d) Quality by Design. [5]

e) Photostability testing of drug and drug products. [5]



[6282]-118 2
Total No. of Questions : 5] SEAT No. :

PB-4657 [Total No. of Pages : 2

[6282]-119
F.Y. [Link]
MRA - 102T : DOCUMENTATION AND REGULATORY
WRITING
(2019 Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Answer any one : [15]

a) Explain drug product and importance of EPDB for drug substance and
drug products.
b) Explain in detail DMF.

Q2) Attempt Any Two : [15]

a) Explain in detail site master file
b) Write a note on ACDT Format.
c) Write a note on Product Development Plan (PDP)
d) Explain in detail Internal and External Audits.

Q3) Attempt Any Three : [15]

a) Write a note on root cause analysis.
b) Write a note on inspection of drug distribution channel.
c) Write a note on preparation and Conduct of Audit.
d) Write a note on ISO risk management standard.
e) Brief on Prior Approval Supplement (PAS).

P.T.O.
Q4) Answer any one : [15]
a) Explain Sugam system of CDSCO.
b) Explain in detail CTD module 3.

Q5) Answer any Three : [15]

a) Explain print pack specifications.
b) Write a note on post approval labeling changes.
c) Write a note on seizure and injunctions.
d) Brief on Post Approval Changes [SUPAC].
e) Write a note on COA.



[6282]-119 2
Total No. of Questions : 5] SEAT No. :
PB4658 [Total No. of Pages : 2

[6282]-120
First Year [Link].
PHARMACEUTICAL BIOTECHNOLOGY
MPB - 103T : Bioprocess Engineering and Technology
(Credit 2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Long answer question (Solve 1 out of 2) [15]

a) Write principle of working, construction, advantages and application of
CSTR.
b) Explain various theories associated with scale down process.

Q2) Medium length answer (Solve 2 out of 4) [15]

a) Explain theories associated with mass transfer with respect to fermentation.
b) Explain diffusional resistance to oxygen requirements of microorganisms.
c) Discuss various principles for process scale up of fermentation.
d) Discuss theory of Mass transfer during Bioprocess.

Q3) Short answer questions (Solve 3 out of 5) [15]

a) Discuss synchronous culture
b) Differentiate batch cultivation and Contineous cultivation system
c) Discuss regulatory aspects of biological products
d) Outline Bioautographic technique
e) Describe various techniques used for cell disruption

Q4) Long answer question (Solve 1 out of 2) [15]

a) Explain Biosynthetic pathways for any one secondary metabolite.
b) Discuss important regulation governing the manufacturing of biological
products.
P.T.O.
Q5) Short notes (Solve 3 out of 5) [15]

a) Computer control in Bioprocess

b) Immobilization of enzyme

c) Bubble column bioreactor

d) Cell disruption techniques

e) Determination of KLa value



[6282]-120 2
Total No. of Questions : 5] SEAT No. :
PB4659 [Total No. of Pages : 2
[6282]-121
First Year [Link]
MPC 103T : ADVANCED MEDICINAL CHEMISTRY
(2019 Credit Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are Compulsory
2) Figure to the right indicates full marks.
3) Do not write anything on question paper except seat number.

Q1) Give rationale of Prodrug design and stages involved in prodrug design, Enlist
different types of Prodrugs with suitable examples. Discuss applications of
Prodrugs. [15]
OR
Give the classification and detail account of first generation H1 receptor
antagonists

Q2) Attempt any two: [15]

a) Discuss Theories of drug receptor interaction.
b) Classify antivirals with suitable example. Write chemistry and mode of
action of amantadine.
c) Describe anticonvulsants interacting with GABAA receptor.
d) Write about antimetabolites as antineoplastic agents.

Q3) Attempt any Three: [15]

a) Explain prodrugs to improve patient acceptability.
b) What is drug resistance? Explain its causes in light of antibiotics.
c) Discuss Chemistry of prostaglandins, leukotrienes and thromboxones.
d) Highlight enzyme inhibitors in medicine.
e) Explain mode of action of salicylates.

P.T.O.
Q4) Discuss about various stages of drug discovery and Explain lead discovery;
Identification, Validation and Diversity of drug targets with suitable examples.[15]
OR
Classify antihypertensive agents with examples and mechanism of action. Give
an account of calcium channel blockers.

Q5) Write short notes on (any three): [15]

a) Significance of High Throughput Screening in drug development.

b) Prodrugs of functional group.

c) Rational design of covalently and non-covalently binding enzyme

inhibitors.

d) Classification and detail account of H1 and H2 receptor antagonists.

e) Role of chirality in selective and specific therapeutic agents.



[6282]-121 2
Total No. of Questions : 5] SEAT No. :
PB4660 [Total No. of Pages : 2
[6282]-122
First Year [Link]
MPG - 103T : PHYTOCHEMISTRY
(Credit 2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidate:
1) Neat and labeled diagrams must be drawn wherever necessary.
2) Figures to the right indicate full marks.
3) All questions are compulsory.

Q1) a) Discuss different chromatographic techniques use in structural elucidation

of plant drugs. [15]
OR
b) Describe in detail Biosynthesis, isolation, purification, characterization
and industrial importance of Ephedrine.

Q2) Attempt any two: [15]

a) Explain in detail application of LCMS in the characterization of herbal
extracts.
b) Explain in detail separation of phytoconstituents by preparative HPLC.
c) Explain in detail the lead structure selection process and structure
development in drug discovery and development.
d) Explain various parameters involved in selection of method and choice
of solvent for extraction.

Q3) Attempt any three. [15]

a) Explain isolation, purification and industrial importance of guggulosterone.
b) Explain isolation, purification and industrial importance of Quercetin
c) Provide principle and working of CCCET technique.
d) Describe in detail advances in Thin layer chromatography for plant drug
analysis.
e) Explain in detail spectroscopic characterization for structural elucidation
of citral.

P.T.O.
Q4) a) What are clinical trials? Elaborate phases of clinical trials and protocol
for clinical studies use for drug discovery and development process.[15]
OR
b) Describe in detail Biosynthesis, isolation, purification, characterization
and industrial importance of piperine.

Q5) Write short note on (any three) : [15]

a) Radiotracer Techniques.
b) Elaborate recent advances in extraction methods for plant drugs with
merits and demerits over conventional methods.
c) Artemisinin in drug discovery and development.
d) Structural Elucidation of Kaempferol.
e) GCMS Fingerprinting.



[6282]-122 2
Total No. of Questions : 5] SEAT No. :
PB4661 [Total No. of Pages : 2
[6282]-123
First Year [Link]
MPH - 103T : MODERN PHARMACEUTICS
(Credit 2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidate:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) a) Explain different methods of drug excipient interaction in detail. Add a

note on stability testing. [15]
OR
b) What is process validation? Give its types and explain validation of cone
blender.

Q2) Attempt any two. [15]

a) Factors affecting dissolution of solid.
b) Qualification of equipment.
c) Explain preparation and stability of self micro emulsifying drug delivery
system.
d) Explain evaluation tests for parenteral in detail.

Q3) Attempt Any Three. [15]

a) Discuss process of materials management.
b) Explain Contour plot as an optimization tool.
c) Dissolution profiles comparison by similarity (f 2) and dissimilarity (f 1)
factor.
d) Explain stability of suspension in detail.
e) Elaborate effect of friction and distribution of forces in tablet compression.
P.T.O.
Q4) a) What is optimization? Explain its applications in pharmaceutical field.
Add a note on optimization parameters. [15]
OR
b) Explain in detail current good manufacturing practices. Add a note on
layout of buildings.

Q5) Write short note on (Any three) [15]

a) Higuchi model.
b) Pharmacokinetic parameters
c) Significance of DSC in preformulation.
d) Compaction profiles.
e) Budget and cost control.



[6282]-123 2
Total No. of Questions : 5] SEAT No. :
PB4662 [Total No. of Pages : 2
[6282]-124
First Year [Link]
MPL - 103T : PHARMACOLOGICAL AND TOXICOLOGICAL
SCREENING METHODS - I
(Credit 2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.

Q1) Discuss the various methods employed in the screening of anti-cancer drugs.[15]
OR
Maintenance and breeding of laboratory animals as per CPCSEA Guidelines.

Q2) Attempt any two : [15]

a) Explain various methods used in screening of immunomodulators.
b) Write the screening methods for anti-inflammatory agents.
c) Write the screening methods of anti-emetic drugs.
d) Describe the screening methods for diuretics agents.

Q3) Attempt any three : [15]

a) Discuss the various methods employed in the screening of analgesic agents.
b) Describe the screening methods for anti-diarrheal agents.
c) Describe the screening methods for anxiolytic agents.
d) Discuss the various methods employed in the screening of Anti-asthmatic
agents.
e) Describe in detail the different in vivo models employed in the screening
Alzheimer disease.

P.T.O.
Q4) Discuss the various methods employed in the screening of Anti-ulcer agents.[15]
OR
Discuss the various methods employed in the screening of nootropics agents.

Q5) Write short notes on any three: [15]

a) Good laboratory practice of experimental animals
b) Euthanasia of experimental animals
c) Immunoassay for digoxin
d) Transgenic animals
e) Alternate to animal experiments



[6282]-124 2
Total No. of Questions : 5] SEAT No. :

PB-4663 [Total No. of Pages : 2

[6282]-125
[Link] (Pharmaceutical Quality Assurance)
MQA - 103T : QUALITY CONTROL AND QUALITY
ASSURANCE
(2019 Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Each question has an internal option.

Q1) Explain in detail the IPQC & FPQC tests for parenteral dosage form according
to India pharmacopoeia. [15]
OR
Explain why it is essential to follow cGMP during manufacturing operations
& control. Discuss about sanitation of manufacturing premises, mix-ups &
cross contamination.

Q2) Attempt Any Two : [15]

a) Explain about scope and importance of Good Laboratory practices.
Summarize the responsibilities of Quality Assurance Unit.
b) Elaborate about maintenance of distribution records.
c) Write in detail about Good Warehousing practices.
d) Explain the in-process and finished product quality control tests for
capsules.

Q3) Attempt Any Three : [15]

a) Explain the concept of process deviation and charge-in of components
in pharmaceutical industry.
b) Discuss in brief the validation parameters of analytical procedures
[Q2(R1)] 1 CH guidelines.
P.T.O.
 c) Enlist quality control tests for rubber closures used as packaging material
in pharmaceutical industry. Discuss any two.
d) Discuss about environmental control in sterile area.
e) Comment on regulated and nonregulated markets concept in
pharmaceuticals.

Q4) Discuss in detail the cGMP guidelines according to schedule M for personnel,
location design and plant layout in pharmaceutical industry. [15]

OR

Explain in detail the concept of Three tier documentation in pharmaceutical

industry. Write a note on Common Technical Document.

Q5) Write short notes on Any Three : [15]

a) Difference between Quality Control and Quality Assurance.

b) Master Batch Record.

c) Expiry date calculation and calculation of Yields.

d) IPQC and FPQC of ointments.

e) CPCSEA guidelines for physical facilities for laboratory animals.



[6282]-125 2
Total No. of Questions : 5] SEAT No. :

PB-4664 [Total No. of Pages : 2

[6282]-126
F.Y. [Link]
MRA - 103T : Clinical Research Regulations
(2019 Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Each question has an internal option.

Q1) Answer any one : [1 × 15 = 15]

a) What is CDSCO guidelines? Explain CDSCO guidelines in detail.
b) Clinical Investigations and Evaluation of Medical Devices and IVD’s.

Q2) Answer Any two : [2 × 7½ = 15]

a) What is GCP? Explain in detail about Indian GCP guidelines.
b) Explain in details about “CFR21 part 320”.
c) Explain E11-Clinical Investigation of medicinal products in the pediatric
population.
d) Write a short note on GHTF study group 5 guidance document.

Q3) Solve Any three : [3 × 5 = 15]

a) Significance of INDA.
b) Explain, Guidance for Industry : Good pharmacovigilance practice and
pharmacoepidemiologic Assessment.
c) Write a short note on General biostatics principles applied in clinical
research.
d) Explain CFR21 part 50 : Protection of Human subjects.
e) Indian GCP Guidelines.

P.T.O.
Q4) Solve any one : [1 × 15 = 15]

a) Explain the origin of ICH and add a note on “Good Clinical Practice
guideline”.

b) What is Institution Review Board? Give the details of Ethics committee

composition, roles, responsibilities, review and approval process.

Q5) Write a note on (any three) : [3 × 5 = 15]

a) Write a note on CFR21 part 320 : Bioavailability and Bioequivalence

Requirement.

b) Patient Information Sheet and Informed consent form.

c) Phase II studies in clinical trial.

d) Data safety Monitoring Board.

e) Role of placebo in Clinical Trials.



[6282]-126 2
Total No. of Questions: 5] SEAT No. :
PB4665 [6282]-127 [Total No. of Pages :2

First Year M. Pharm.

PHARMACEUTICAL BIOTECHNOLOGY
MPB-104T:Advanced Pharmaceutical Biotechnology
(Credit 2019 Pattern) (Semester-I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Long answer question. (Solve 1 out of 2) [15]

a) Discuss various sources of enzymes and their therapeutic & clinical
applications.
b) Explain various drug delivery approaches for therapeutic proteins.

Q2) Medium length answers. (Solve 2 out of 4) [15]

a) Write the principle of genetic engineering. Discuss various applications
of genetic engineering.
b) Briefly explain role of various oncogenes proteins.
c) Discuss various purification techniques for enzymes production.
d) Discuss DNA sequence analysis methods.

Q3) Short answer questions. (Solve 3 out of 5) [15]

a) Write the role of cloning vectors in r-DNA technique.
b) Discuss principle and applications of PCR.
c) Write the applications of Biotransformation.
d) Describe flow chart for the production of amylase enzyme.
e) Explain site directed mutagenesis.
P.T.O.
Q4) Long answer question. (Solve l out of 2) [15]
a) What are Transgenic Animals? Write their applications in production of
therapeutic proteins.
b) Explain in details about kinetics of enzyme activity.

Q5) Short notes. (Solve 3 out of 5) [15]

a) Expression vectors in r-DNA
b) Transgenic animals
c) Human Genome Project
d) Write a note on c-DNA
e) Gene therapy



[6282]-127 2
Total No. of Questions: 5] SEAT No. :
PB4666 [6282]-128 [Total No. of Pages :2

First Year M. Pharm.

PHARM CHEMISTRY
MPC 104 T : Chemistry of Natural Products
(2019 Credit Pattern) (Semester-I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labelled diagrams wherever necessary.

Q1) Solve any 1 question out of 2 [15]

Explain how CNS drug development has progressed from plant products.
OR
Define Alkaloids. Describe isolation and purification of Alkaloids. Explain
structural elucidation of Alkaloids with example.

Q2) Solve any 2 questions out of 4 [2×7½=15]

a) What are characterization details for Digitalis glycosides?
b) Explain development of Etoposide derivatives as anticancer agents.
c) What are Flavonoids? Elucidate the structure of Quercetin.
d) Discuss in brief about rDNA technology.

Q3) Answer any 3 questions out of 5 [3×5=15]

a) Write structure elucidation methods for Flavonoids.
b) Explain chemistry of Beta lactam antibiotics.
c) Explain the significance of isoprene rule.
d) Discuss the chemistry of Testosterone.
e) Discuss physiological significance of Vitamin D.
P.T.O.
Q4) Answer any 1 question out of 2 [15]
Explain nomenclature and chemistry of oral contraceptive agents giving their
structures.
OR
What is gene therapy? Explain clinical applications and recent advances in
gene therapy.

Q5) Write short notes on any 3 out of 5 [3×5=15]

a) Physiological significance of Vitamin C.
b) Development of curare alkaloids as neuromuscular blocking agents.
c) Describe the active constituents in Curcuma longa Linn for antitumor
property.
d) Describe the structural elucidation of Squaline.
e) Explain principles of RNA & DNA estimation.



[6282]-128 2
Total No. of Questions: 5] SEAT No. :
PB4667 [6282]-129 [Total No. of Pages :2

First Year M. Pharmacy (Pharmacognosy)

MPG 104T : INDUSTRIAL PHARMACOGNOSTICAL
TECHNOLOGY
(2019 Credit Pattern) (Semester-I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labelled diagram wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) What are current challenges in upgrading and modernization of herbal

formulations? [15]
OR
What are scale up techniques for process optimization, maximization of
productivity, in process control techniques? [15]

Q2) Attempt Any Two [15]

a) Explain quality management systems with context to ISO.
b) Explain global regulatory status of herbal medicines.
c) What are parameters of monograph of herbal drugs in Indian
Pharmacopoeia?
d) What are methods of stability testing of natural products?

Q3) Attempt any Three [15]

a) What is clinical laboratory testing of natural products?
b) Write note on “Geographical indications”
c) What are set of guidelines and instructions related to import and export
of goods in India?
d) Explain safety parameters foe quality assessment of herbals as per WHO
guidelines?
e) What are the methods of selecting projects?
P.T.O.
Q4) What are infrastructural requirements of herbal industry involved in
production of herbal dosage forms. [15]
OR
What are policies for import and export of herbal drugs in India? [15]

Q5) Write short note on (Any Three) [15]

a) ISO9000
b) Patent opposition
c) GLP
d) Total Quality Management
e) Trade-Related Aspects of Intellectual Property Rights



[6282]-129 2
Total No. of Questions: 5] SEAT No. :
PB4668 [6282]-130 [Total No. of Pages :2

First Year M. Pharm.

MPH 104 T : REGULATORY AFFAIRS
(2019 Credit Pattern) (Semester-I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Long answer questions (Any 1) [1×15=15]

a) Explain in details about the Drug Price Competition and Patent Term
Restoration Act.
b) Describe the regulatory requirements of medical devices for market
authorization.

Q2) Medium length answers (Any 2) [2×7.5=15]

a) Explain the concept of BA and BE with special emphasis on its
outsourcing in CRO.
b) Illustrate various manufacturing practices followed during CMC.
c) Discuss USFDA regulatory concept of combination product with
example.
d) Describe in brief about CFR. Give details about CFR 21.

Q3) Short Answers (Any 3) [3×5=15]

a) Describe about post approval studies for product in regulation for CMC.
b) Give details about IND filling in India.
c) What is investigator brochure (IB)? Give the main content of it.
d) Describe in details about DMF.
e) Regulatory requirements of TGA and its objectives.
P.T.O.
Q4) Long answer questions (Any 1) [1×15=15]
a) Explain in detail regulatory requirement for product approval with special
emphasis on NDA and ANDA.
b) Describe the regulatory requirement of combination products for market
authorization.

Q5) Short notes (Any3) [3×5=15]

a) SUPAC
b) Investigation of Medicinal Products Dossier (IMPD)
c) Guidelines ICH-Q
d) Common Technical Document (CTD)
e) Institutional Review Board (IRB)



[6282]-130 2
Total No. of Questions : 5] SEAT No. :

PB-4669 [Total No. of Pages : 2

[6282]-131
[Link]
MPL - 104T : Cellular and Molecular Pharmacology
(2019 Pattern) (Semester - I)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw neat labeled diagrams wherever necessary.

Q1) Write detail account of gene therapy and its clinical applications. [15]
OR
Explain in detail, Polymerase chain reaction and its applications.

Q2) Attempt ANY TWO : [15]

a) What do you mean by DNA recombinant technology? Discuss its
applications.
b) Explain the mechanism of apoptosis.
c) How cell cycle is regulated?
d) Write note on gene transfer techniques.

Q3) Attempt ANY THREE : [15]

a) Describe inter cellular signaling.
b) Explain the principle and applications of cell viability assay.
c) Discuss the role of genetic variation in drug transporters.
d) Explain mitogen activated protein kinase signaling.
c) Differentiate between necrosis and apoptosis.

P.T.O.
Q4) What are second messengers? Explain role of Cyclic AMP, Calcium ion and
Nitric oxide as second messengers. [15]
OR
Define and classify receptors. Discuss in detail molecular structure and signal
transduction via GPCRs

Q5) Write short note on (ANY THREE) : [15]

a) Protein engineering.

b) DNA based diagnosis of diseases.

c) Applications of biosimilars.

d) Nuclear receptors.

e) Cellular aging and death.



[6282]-131 2
Total No. of Questions : 4] SEAT No. :
PB-4670 [Total No. of Pages : 2

[6282]-132
[Link]
PHARMACEUTICAL QUALITY ASSURACE
MQA104 T : Product Development & Technology Transfer
(2019 Pattern) (Semester-I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates :
1) All questions are compulsory
2) Figures to the right indicate full marks.

Q1) What is technology transfer? Give its importance in pharmaceutical

industries? Discuss in details various steps involved in technology transfer.[15]
OR
What are SUPAC & BACPAC? Discuss in detail SUPAC guidelines for change
in formulation, site, equipment & process along with suitable examples.

Q2) Attempt any two. [15]

a) What are phase IV studies? How they differ from phase I/II/III clinical
studies.
b) Discuss role of surfactants & co-solvents in solubility enhancement along
with suitable examples.
c) Describe the aspects & functions of pharmaceutical packaging.
d) What is pre-formulation studies? Discuss about importance of crystanility
& polymorphism in preformulation studies?

Q3) Attempt any three. [15]

a) Give quality control tests for glass as packaging material.
b) Define pilot plant scaleup? Discuss the challenges in scale up of new
drug product.
c) Discuss the development & information contents of ANDA.
d) What is aseptic packaging system? What are its advantages? Write about
methods of sterilization of aseptic packaging materials & equipments.
e) Describe the registration guidelines for dosage form as per us FDA.

P.T.O.
Q4) Discuss in detail stability testing during product development as per ICH guide-
lines. [15]
OR
Describe large scale manufacturing techniques including formula, equipment,
process, stability & quality control for solid dosage form in detail.

Q5) Write short notes on Any three. [15]

a) Post marketing surveillance
b) Pharmaceutical packaging.
c) Medical device packaging.
d) SNDA
e) Importance of micromeritics & flow properties in performulation.



[6282]-132 2
Total No. of Questions : 5] SEAT No. :

PB-4671 [Total No. of Pages : 2

[6282]-133
[Link]
MRA - 104T : Regulations & Legislation for Drugs &
Cosmetics, Medical Devices, Biologicals & Herbals, and
Food & Nutraceuticals in India and Intellectual Property
Rights
(2019 Pattern) (Semester - I)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Answer any one : [15]

a) Explain IPR and various components of intellectual Property Rights
b) Discuss rules, guidelines and procedures under Medicinal and Toilet
Preparations (Excise Duty) act 1955.

Q2) Answer any two (7½ Marks each) : [15]

a) Discuss organisation and significance of CDSCO and SLA.
b) Mention the conditions of import license for schedule C and schedule X
drugs.
c) Discuss in detail rules and responsibilities of DPCO.
d) Comment on prohibition of misleading advertisement relating to drugs
under drugs & magic remedies act 1955.

Q3) Answer any three (5 marks each) : [15]

a) Give format & content of Regulatory Dossier filing.
b) Differentiate between copyright infringement & Trademark infringement.
c) Discuss regulatory requirements of Bioequivalence study.

P.T.O.
 d) Give rules, regulations, guidelines & standards for regulatory filing of
biological and herbals.
e) Give brief guidelines for drug testing in animals/preclinical study.

Q4) Answer any one (15 marks each) : [15]

a) Discuss in detail about Indian pharmacopoeia standards, BIS, ISO and
other relevant standards.
b) Explain in detail Drugs and Cosmetics act 1940 and rules.

Q5) Write Short Notes on any three (5 marks each) : [15]

a) Copyright & work protected under copyright act
b) Industrial designs and Geographical Indications
c) Schedule X
d) Prevention of cruelty to animals act
e) Define and give role
i) Registered Medical Practitioner
ii) Drugs
iii) ISO
iv) NPPA
v) CPCSEA



[6282]-133 2
Total No. of Questions : 5] SEAT No. :
PB4672 [6282]-211
[Total No. of Pages :2

First Year M. Pharm.

MPB 201 T : PROTEINS & PROTEIN FORMULATION
(2019 Credit Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labelled diagram wherver necessary.

Q1) Attempt any one from the following. [15]

a) Classify Peptidomimetics in detail with example.

b) Explain in brief about 2D - Gel electrophoresis with its principle &

applications.

Q2) Attempt any two from the following. [15]

a) Describe CADD techniques in Peptidomimetics.

b) Discuss forced degradation studies relevance to development of protein

therapeutics.

c) Explain types of mass spectrometry for protein structure

d) What are the different methods of gel electrophoresis?

Q3) Attempt any three from the following. [15]

a) Explain various chromatographic techniques in protein purification.

b) Describe in brief liposomes in protein formulation.

c) What are the properties & benefits of PEGylation in protein formulations?

d) Enlist the stability problems in proteins? Explain in brief.

e) How does Edman degradation help in protein sequencing?

[6282]-211 1 P.T.O.
Q4) Attempt any one from the following. [15]

a) Enlist various methods for protein sequencing. Explain Edman degradation

technique in detial.

b) How proteins can be purified & Enlist? Explain the different methods
used for the protein purification.

Q5) Write short notes on (any 3) [15]

a) Neo Spears.

b) Development of non - peptide Peptidomimetics.

c) Reproducibility and image analysis.

d) A note on Rai - Farnesyl transferase inhibitors.

e) Desuss Isolation of intracellular protein.



[6282]-211 2
Total No. of Questions : 5] SEAT No. :
PB4673 [6282]-212
[Total No. of Pages :3

First Year M. Pharmacy.

MPC 201 T : ADVANCED SPECTRAL ANALYSIS
(2019 Credit Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Black figures to the right indicate full marks.
3) Neat labelled diagrams must be drawn wherver necessary.

Q1) Explain principle, instrumentation and applications of GC-MS. [15]

OR

Explain Woodward - Fieser rule for assessment of max for 1,3- butadienes
and 

 carbonyl compounds.

Predict the max for each of the following compounds

Q2) Attempt any two. [15]

a) Explain COSY and HETCOR techniques.

b) Explain principle and instrumentation of Supercritical fluid

Chromatography.

c) Explain Mc - Lafferty rearrangement with suitable example

[6282]-212 1 P.T.O.
 d) Explain the number of signals and their splitting, if any in the following
compounds.

Q3) Attempt any three. [15]

a) Explain use of thermal methods in analyses of pharamaceutical drugs

with suitable example.

b) Explain analysis of following class of compounds by IR Spectroscopy

(any two)

i) Amines

ii) Alcohols

iii) Carbonyl compounds

c) What is ortho effect in mass spectrometry? Explain with example.

d) Discuss the radioimmunoassay of digitalis or insulin.

e) How hydrogen bonding in alcohols affects absorption position (in cm-1)

in IR spectrum? Explain with suitable example.

[6282]-212 2
Q4) a) Find out the probable structure of compound from the following data;[15]

MF: C10H14

IR (cm-1): 3102, 2967, 2890. 1590-1601

1
H NMR (ppm): i) Singlet, 6H

ii) multiplet, 1H

iii) doublet, 2H

iv) Singlet, 5H

b) Write a note on LC - FTIR.

OR

Explain different rules used in fragmentation of organic compounds in mass

spectrometry.

Q5) Write short notes on (any Three) [15]

a) Bioassay.

b) Flash Chromatography.

c) ELISA.

d) ATR in IR spectroscopy.

e) Ring Rule in MS.



[6282]-212 3
Total No. of Questions : 5] SEAT No. :

PB-4674 [Total No. of Pages : 2

[6282]-213
M. Pharmacy
MPG 201T : MEDICINAL PLANT BIOTECHNOLOGY
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) What is transgenic plant? Describe various methods used in gene identification,
localization and sequencing of genes. [15]
OR
Describe historical perspective and prospectus of the development of plant
biotechnology.

Q2) Soleve any Two : [15]

a) Explain DNA replication and its significance.
b) What is fermentation? Give its application in pharmacy and allied fields.
c) Write about cloning of plant cell and its applications.
d) Discuss hairy root multiple shoot cultures and their applications.

Q3) Attampt any Three : [15]

a) Define plant biotechnology. Give applications in pharmacy and allied
fields.
b) Write a note on ‘r-DNA technology’.
c) Explain the regulation of gene expression with suitable example.
d) Define protoplasm. Explain the process of protoplast fusion with example.

P.T.O.
Q4) What is cloning of plant cell? Describe different methods of cloning with its
[Link] its advantages and disadvantages. [15]

OR

What is RNA? Give its types. Explain RNA replication with its significance.

Q5) Write a short note on the followings (Any Three) : [15]

a) Biotransformation.

b) Organogenesis and Embryogenesis

c) Single cell protein

d) Sterilization methods in tissue culture



[6282]-213 2
Total No. of Questions : 5] SEAT No. :

PB-4675 [Total No. of Pages : 2

[6282]-214
First Year M. Pharmacy
MPH 201T : MOLECULAR PHARMACEUTICS
(NANO TECH & TARGETED DDS)
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw neat labeled diagram wherever necessary.

Q1) Solve any one out of two. [15]

Discuss preparation of monoclonal antibodies with application.
OR
Describe in detail methods of preparation and applications of niosomes.

Q2) Soleve any two out of four. [15]

a) Explain preparation, evaluation of nanoparticle.
b) Explain liposomal gene therapy.
c) Discuss different approaches for drug targeting.
d) Explain preparation and evaluation of aquasomes.

Q3) Short answer questions (Solve 3 out of 5) [15]

a) Explain methods of preparation of Microspheres.
b) Discuss components of aerosol.
c) Explain endocytosis and extravasation.
d) Discuss aptamer as drug of future.
e) Comment on advantages of antisense molecules.

P.T.O.
Q4) Long answer question (Solve 1 out of 2) : [15]

Write in detail on methods of preparation and evaluation of liposomes.

OR

Discuss different types of intra nasal route delivery system and explain factors
affecting nasal drug absorption.

Q5) Write short note on (Solve 3 out of 5) [15]

a) Liposomal gene therapy

b) Brain targeting

c) Phytosomes

d) Propellant

e) In-vivo gene therapy



[6282]-214 2
Total No. of Questions : 5] SEAT No. :

PB-4676 [Total No. of Pages : 2

[6282]-215
M. Pharmacy
MPL 201T : ADVANCED PHARMACOLOGY - II
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw neat labeled diagrams wherever necessary.

Q1) Answer the following (1 out of 2) : [15]

a) Classify anti-TB drugs, write the mechanism of action, adverse effects,
therapeutic uses and interactions of Isoniazid.

b) Classify contraceptives. Explain the pharmacology of hormonal

contraceptives.

Q2) Soleve any two out of four : [15]

a) Write the mechanism of action, therapeutic uses and toxicity of Nevirapine.
b) Write the pharmacology of Anti-thyroid drugs belongs to the class
thioamide derivatives.
c) Write the mechanism of action, spectrum of activity and therapeutic uses
ofsecond-generation Fluroquinolones,
d) Classify anti-asthmatics, write the mechanism of action and therapeutic
uses of Salbutamol.

Q3) Answer the following (Solve 3 out of 5) : [15]

a) Define antioxidants. Write the role of free radicals in the etiopathology of
diabetes.
b) Explain role of chronotherapy in Asthma.
P.T.O.
 c) Classify antifungal drugs. Write mechanism of action and antimicrobial
spectrum of Flucytosine.
d) Classify anticancer drugs. Write mechanism of action of Methotrexate.
e) Write a note on laxatives

Q4) Answer the following (Solve 1 out of 2) : [15]

a) Explain in brief various mechanisms of antibiotic resistance.

b) Classify Antiviral agents. Write a note on antiretroviral agents in detail.

Q5) Write short note on (Solve 3 out of 5) : [15]

a) Macrolide antibiotics.

b) COPD.

c) Metronidazole.

d) Vitamin E as an antioxidant.

e) Probiotics in Dirrhoea.



[6282]-215 2
Total No. of Questions : 5] SEAT No. :

PB-4677 [Total No. of Pages : 2

[6282]-216
M. Pharmacy
MQA 201T : PHARMACEUTICAL QUALITY
ASSURANCE
HAZARDS AND SAFETY MANAGEMENT
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) Explain components of Fire triangle and classification of Fire. Add a note on
the preventive and protective management from fire and explosions. [15]
OR
What is air based hazards. Discuss in detail air circulation maintenance in
pharmiceutical industry for sterile area.

Q2) Attempt any Two : [15]

a) Define Industrial hazard and risk. Discuss sources of fire hazards and
explosions.
b) Discuss the ICH guideline on risk assessment.
c) Discuss the control measures while handling flammable material, dust
explosions and pyrophoric material.
d) What is MSDS? Discuss the sections of MSDS.

Q3) Attempt any Three : [15]

a) Write a note on fire extinguishment.
b) Discuss the control strategies while handling combustible gases and
sulphonating reagents.
P.T.O.
 c) Explain the self-protective measure against workplace hazards.
d) Explain the effluent treatment procedure in an industry.
e) What is TLV concept? Discuss its significance and various threshold
limits.

Q4) Explain in detail various risk management tools used in industry. [15]

OR

Discuss the hazards associated with organic solvent. Add a note on safety
measures taken while handling organic solvents.

Q5) Write a short note on (Any Three) : [15]

a) Explain the Elements of Safety Management Programme.

b) Write a note on Factory act and rules.

c) Write in brief about BOD and COD.

d) Enlist and explain various renewable and non-renewable natural resources.

e) Explain the concept of ecosystem with its structure and function



[6282]-216 2
Total No. of Questions : 5] SEAT No. :

PB-4678 [Total No. of Pages : 2

[6282]-217
M. Pharmacy
MRA 201T : REGULATORY ASPECTS OF DRUGS AND
COSMETICS
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Describe PMDA? Write about the master file system for drug substances in
Japan. Write briefly about post marketing surveillance in Japan. [15]
OR
Explain the regulatory requirements for registrations of drugs and post approval
requirement in South Korea.

Q2) Attampt any Two : [15]

a) Discuss Active Substance Master Files (ASMF) system in EU.
b) Explain the committees across globe : APEC, EAC.
c) Enlist the regulatory requirements for registration of drugs and post
approval requirements in ASEAN.
d) Describe regulatory pre-requisites related to marketing authorization
requirements for drugs in Russia.

Q3) Attampt any Three : [15]

a) Describe Federal register and Code of Federal Regulations (CFR).
b) Explain Qualified Person (QP) in EU.
c) Describe Marketing Authorization procedures in EU (Centralized
procedure).
d) Discuss regulations for manufacture and sale of cosmetics in GCC
countries.
e) Describe the regulations of sale of cosmetics in CIS countries.
P.T.O.
Q4) Describe Legislation and regulations for import, manufacture, distribution and
sale of cosmetics in Japan. [15]

OR

Explain the regulatory requirements for registrations of drugs and post approval
requirements in China.

Q5) Write short notes on (Any Three) : [15]

a) Supplemental New Drug Application (SNDA)

b) Eudralex directives for human medicines

c) PANDRH

d) Certificate of Pharmaceutical Product

e) ACTD



[6282]-217 2
Total No. of Questions : 5] SEAT No. :

PB-4679 [Total No. of Pages : 2

[6282]-218
[Link] (Pharmaceutical Biotechnology)
MPB - 202T : IMMUNOTECHNOLOGY
(2019 Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.

Q1) Long answer questions (Solve 1 out of 2) : [15]

a) Discuss in detail about Antigen Presenting Cells, their types and functions.
OR
b) What are cytokines? Explain their biological functions.

Q2) Medium Length answer (Solve 2 out of 4) : [15]

a) Discuss on MHC complex.
b) Discuss detail structure and functions of antibody.
c) Write advantages and drawbacks of live attenuated vaccines.
d) Explain various types of Autoimmune disorders.

Q3) Short answer questions (Solve 3 out of 5) : [15]

a) Explain Conjugate vaccines.
b) Explain compliment activation and its types.
c) Write functions of cytokines.
d) Write functions of different types of T-cells.
e) Give examples of various traditional vaccines preparations.

P.T.O.
Q4) Long answer questions (Solve 1 out of 2) : [15]

a) Outline different types of vaccines. Discuss on Anti-idiotypic vaccine.

OR

b) Discuss in detail about Recombinant vaccines with suitable examples.

Q5) Short notes (Solve 3 out of 5) : [15]

a) Opsonization.

b) Antigen-Antibody Interaction Reactions.

c) DNA vaccine.

d) Applications of Stem Cell in Immunology.

e) Mechanism of Phagocytosis.



[6282]-218 2
Total No. of Questions : 5] SEAT No. :

PB-4680 [Total No. of Pages : 2

[6282]-219
First Year [Link] (Pharmaceutical Chemistry)
MPC - 202T : ADVANCED ORGANIC CHEMISTRY - II
(2019 Pattern) (Semester - II) (Theory)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on the question paper except seat number.

Q1) Describe chiral auxiliary method of asymmetric synthesis using suitable

examples. Add a note on uses of enzymes in asymmetric synthesis. [15]
OR
Explain Transition metal catalysed and Organo - catalysis based reactions
with suitable examples.

Q2) Attempt Any Two : [15]

a) Cite an example of cycloaddition reaction to explain the Frontier molecular
orbital approach.
b) Elaborate on Types of sonochemical reaction. Add a note on their
synthetic applications.
c) What is Ziegler-Natta catalyst? Explains its applications.
d) Explain examples of ionic liquids and their applications.

Q3) Attempt Any Three : [15]

a) Define optical activity, specific rotation and Racemic modification with
suitable examples.
b) What is Wilkinson’s Catalyst? Explain its applications in Organic
synthesis.
P.T.O.
 c) Explain stereochemical aspects of Diel’s Alder reaction.
d) Discuss Merits and Demerits of microwave assisted reactions.
e) Discuss Phase Transfer Catalysis with suitable examples.

Q4) What are types of catalysis? Explain suitable examples of each. Add a note on
the advantages and disadvantages of each. [15]

OR

Explain thermal and photochemical electrocyclic reactions. Explain the terms,

Conrotatory and Disrotatory by citing suitable examples.

Q5) Write short notes on (Any Three) : [15]

a) Continuous flow reactors.

b) Solid supports in peptide synthesis.

c) Elements of Symmetry.

d) Applications of Biocatalysis.

e) Sequence rules with suitable examples.



[6282]-219 2
Total No. of Questions : 5] SEAT No. :

PB-4681 [Total No. of Pages : 2

[6282]-220
First Year M. Pharmacy
MPG 202T : ADVANCED PHARMACOGNOSY - II
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) Define adulteration. Describe various methods of adulteration. Explain causes

and measures of adulteration. [15]
OR
Explain analytical profile of following herbal drugs -
a) Embellica officinalis.
b) Psoralea corylifolia.

Q2) Soleve any two : [15]

a) Explain DNA finger printing technique in identification of herbal drugs.
b) Explain role of ethnobotany in herbal drug evaluation.
c) Describe In vivo evaluation methods for anti-inflammatory activity.
d) Write analytical profile of Curcuma longa.

Q3) Attampt any Three : [15]

a) Write about efficacy of herbal medicinal products.
b) Describe microbial contamination in herbs and their formulations.
c) Explain impact of ethnobotany in traditional medicine.
d) Give analytical profile of Boswellia serata.
e) Write about need of phytopharmacological screening in brief.
P.T.O.
Q4) What is ethnobotany and ethnopharmacology? Describe role of
ethnopharmacology in drug evaluation. [15]

OR

Explain toxicity studies as per OECD guidelines.

Q5) Write short note on the following (Any Three) [15]

a) Reverse Pharmacology

b) In vitro evaluation technique for anti-oxidant activity.

c) Determination of Phycotoxin

d) Analytical profile of Andrographis paniculata

e) Bioprospecting tools for drug discovery.



[6282]-220 2
Total No. of Questions : 5] SEAT No. :

PB-4682 [Total No. of Pages : 2

[6282]-221
M. Pharmacy
MPH 202T : ADVANCED BIOPHARMACEUTICS AND
PHARMACOKINETICS
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Neat labelled diagrams must be drawn wherever necessary.
3) Use of Non-Scientific Calculator is not allowed.

Q1) Discuss in Detail about assumptions, importance and limitations of pH-partition

Hypothesis. [15]

OR

Discuss the importance of Dissolution in drug product development. Elaborate

on compendial and non-compendial methods of in-vitro dissolution testing.
How Dissolution profiles are compared?

Q2) Answer the following (any Two) : [15]

a) Describe briefly factors affecting gastric emptying of drug. Add a note

on importance of this factor in drug absorption.

b) Explain the methods used to calculate ka for the drug administered by

extravascular method following one compartmental kinetics.

c) Compare absolute and relative bioavailability. Elaborate on various study

designs used for bioequivalence studies.

d) Discuss various important pharmacokinetic parameters and how they

can be determined?

P.T.O.
Q3) Answer the following (Any 3). [15]
a) A 60 Kg patient is to be given an antibiotic by i.v. infusion. The drug has
half-life of 18 hours, apparent volume of distribution Vd 12.5 litres and
the desired Css is 0.0012 mcg/ml. Assuming one compartmental kinetics,
calculate infusion rate Ro to achieve desired Css and Loading dose
(i.v. bolus) to achieve Css
b) What is non-linear kinetics? Give reasons with examples for non-linear
kinetics shown by drugs.
c) List various factors affecting absorption and explain in detailed
Pharmaceutical factors affection absorption of drug from GI tract.
d) Describe the possible mechanisms for drug transport through GIT.
e) Write a note of Generic Biologics or Biosimilars.

Q4) Describe in Detail the importance of IVIVC and various types of IVIVC.[15]

OR

What are drug interactions. Comment on their applications. Discuss

Pharmacokinetic Drug interactions with examples.

Q5) Write short note on (Any Three) : [15]

a) Rate method for estimation of elimination rate.

b) Effect of food on bioavailability of drug.

c) Pharmacokinetic applications to modified drug release product.

d) Biopharmaceutical classification system.

e) Therapeutic drug monitoring.



[6282]-221 2
Total No. of Questions : 5] SEAT No. :

PB-4683 [Total No. of Pages : 2

[6282]-222
M. Pharmacy
MPL 202 T : PHARMACOLOGICAL AND
TOXICOLOGICAL SCREENING METHODS - II
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Neat labeled diagrams must be drawn wherever necessary.
3) Figures to the right indicate full marks.

Q1) Attempt any one : [15]

a) Discuss the key features of ICH guidelines for toxicity studies.
b) Discuss in brief about origin, concepts and importance of safety
pharmacological studies.

Q2) Attempt any Two : [15]

a) Explain the importance of EPA guidelines for toxicity studies.
b) Define IND. Write the list of studies needed for IND submission.
c) Write the alternative methods for animal toxicity studies.
d) Explain how will you test the compound for carcinogenicity?

Q3) Attempt any Three : [15]

a) Describe in detail the Tier 1 ana Tier 2 safety pharmacology studies.
b) Explain the types of toxicity studies with examples.
c) Discuss acute eye irritation studies.
d) Write the inhalation study as per OECD guideline.
e) Explain in vivo and in vitro genotoxicity studies.
P.T.O.
Q4) Attempt any one : [15]

a) Explain the importance and methods for test item characterization in

regulatory toxicity study.

b) Define acute, chronic and subacute study. Explain the process of

determining LD50 in acute toxicity testing of drugs as per OECD
guidelines.

Q5) Write short note on (Any Three) : [15]

a) Teratogenicity studies (Segment II)

b) Dermal irritation studies.

c) Importance of Toxicokinetics

d) Schedule Y

e) HERG assay



[6282]-222 2
Total No. of Questions : 5] SEAT No. :

PB-4684 [Total No. of Pages : 2

[6282]-223
M. Pharmacy
MQA 202 T : PHARMACEUTICAL VALIDATION
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to right indicate full marks.

Q1) Attempt any One question of the following : [15]

a) What is Validation? Explain the Scope, Importance, frequency and
advantages of Validation.

b) Discuss various means to protect Intellectual Property. Comment on the

process of application for and maintenance of International Patent.

Q2) Attempt any Two questions of the following : [15]

a) Elaborate qualification of Hardness Tester.
b) Explain difference between Calibration and Validation.
c) How is validation of analytical method done for a method used in cleaning
validation?
d) What are the principles of GAMP’s risk based approach to Computer
System Validation?

Q3) Attampt any Three questions of the following : [15]

a) Qualification of Membrane filtration.
b) Qualification of Dissolution test apparatus as per USP.
c) Explain the sampling in cleaning method validation.
d) Write a short note on “Copyrights”.
e) When is Revalidation essential?

P.T.O.
Q4) Attempt any One question of the following : [15]

a) Explain the Qualification of UV Visible spectroscopy.

b) Discuss in details, the three stages of process validation.

Q5) Write short note on any Three of the following : [15]

a) Calibration of weights & measures.

b) Organization for Validation.

c) FTIR qualification as per Indian Pharmacopoeia.

d) Electronic Signature

e) Prospective validation



[6282]-223 2
Total No. of Questions : 5] SEAT No. :

PB-4685 [Total No. of Pages : 2

[6282]-224
M. Pharmacy
MRA 202T : REGULATORY ASPECTS OF HERBALS &
BIOLOGICALS
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Explain marketing authorization procedure for vaccine regulations in European

Union. [15]
OR
Write in detail about packing & labelling requirements for biologicals as per
USFDA.

Q2) Attempt any Two : [15]

a) Explain what are the CTD module 3 data requirements for market
authorization application as per India.
b) Write a note on pluma master file.
c) Note on: Quality, safety and legislation for herbal products in India.
d) Write a note on pharmacovigilance.

Q3) Attempt any Three : [15]

a) What are the data requirements for preclinical studies as per India
regulations?
b) Write down difference between generic drugs and biosimilars.
c) What are the stability requirements for vaccines as per European Union?
d) Discuss the TSE/ BSE evaluation.
e) What are the principles for establishing biosimilarity?

P.T.O.
Q4) Write in detail about GMP requirements for biologicals as per Indian
regulations. [15]

OR

Explain in detail BLA application process as per USA.

Q5) Write short note on (Any Three) : [15]

a) What are the labeling requirements for blood products as per USA
regulations?

b) Data Requirements for Market Authorization Application as per USA.

c) What are the safety requirements for vaccines as per European Union?

d) Write a note on advertising regulations as per EU.

e) Emphasize on Additional requirements Blood and Blood Products

Regulations in US.



[6282]-224 2
Total No. of Questions : 5] SEAT No. :
PB4686 [6282]-225
[Total No. of Pages :2

First Year M. Pharmacy (Pharmaceutical Biotechnology)

MPB 203 T : BIOINFORMATICS AND COMPUTER
TECHNOLOGY
(Credit 2019 Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labelled diagrams wherever necessary.

Q1) Long answer question (Solve 1 out of 2). [15]

a) Define bioinformatic. What are bioinformatic database? Discuss five major

types of bioinformatic databases.

OR

b) Write a note on sequence analysis.

Q2) Medium length answer (Solve 2 out 4) [15]

a) Discuss protein informatics.

b) What is drug designing? Explain the principle of drug design.

c) Write a note on protein folding.

d) What is multiple sequence alignment?

Q3) Short answer questions (Solve 3 out of 5) [15]

a) Discuss five major types of bioinformatic databases.

b) Write a note on structural databases.

c) Write about five types of data used in Bioinformatics.

d) Write application of Bioinformatics.

e) Write about five types of data used in Bioinformatics.

[6282]-225 1 P.T.O.
Q4) Long answer question (Solve 1 out of 2) [15]

a) What is lead discovery? Explain application of bioinformatics in

microarray analysis?

OR

b) Discuss kind of docking and methods of protein ligand docking.

Q5) Short notes (Solve 3 out of 5) [15]

a) Explain in detail Genetic mapping.

b) Write a note on Nematode biology.

c) What is MUSCLE?

d) Explain the principle of drug design?

e) Explain in detail Genetic mapping.



[6282]-225 2
Total No. of Questions : 5] SEAT No. :
PB4687 [6282]-226
[Total No. of Pages :2

First Year M. Pharmacy (Pharmaceutical Chemistry)

MPC - 203 T : COMPUTER AIDED DRUG DESIGN
(Credit 2019 Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Answer to the two sections should be written in separate answer books.
3) Neat labeled diagrams be drawn wherever necessary.
4) Figures to the right indicate full marks.

Q1) a) Describe the advancement of drug design in the field of HMG-CoA

reductases focusing on the role of CADD. [15]
OR
b) Citing suitable examples explain the role of CADD in drug discovery.
[15]
Q2) Attempt Any Two. [15]
a) What is a Conformational analysis? Explain the process in detail citing a
suitable example.
b) Explain the process of Free Wilson analysis.
c) Explain the process of Energy Minimization Methods employed in
Molecular Modeling and Docking.
d) Detail the principle and application of Hansch analysis in development
of CADD.
Q3) Attempt Any Three. [15]

a) Explain generation of a protein structure to be used in molecular modeling.

b) What is AchE? Explain the process of studying molecular docking and

drug receptor interactions with AchE.

c) Describe the process of predicting the functional components in

receptor / enzyme and studying the cavity size.

d) Describe various strategies to design and develop drug molecules.

[6282]-226 1 P.T.O.
 e) What are the in silico screening protocols for drug design.

Q4) a) Describe the importance of molecular and quantum mechanics in drug

design. [15]

OR

b) Give a detailed account on the use of CADD for predicting ADMET

properties of new chemical entities for drug likeliness. [15]

Q5) Write Short notes any Three. [15]

a) Analysis of a receptor (or enzyme) - interaction.

b) Explain the experimental and theoretical approaches for the determination

of physico-chemical parameters of drug-like molecules.

c) Contour map analysis.

d) Development of agents acting on HMG-CoA reductase using CADD.

e) Hansch analysis.



[6282]-226 2
Total No. of Questions : 5] SEAT No. :
PB4688 [6282]-227 [Total No. of Pages : 2

First Year [Link](Pharmacognosy)

SUB:MPG-203T : INDIAN SYSTEM OF MEDICINE
( Credit 2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75]
Instructions to the candidates:
1) All questions are compulsory.
2) Draw well labelled diagrams wherever necessary.
3) Figures to the right indicate full marks.

Q1) Discuss principles of treatment in Homeopathy system of medicines. [15]

OR
Explain Document preparation for new drug application and export registration.

Q2) Answer the following (Any-two) [15]

a) Explain TKDL in detail.
b) Explain preparation technique as per Unani Pharmacopeias.
c) Explain challenges in monitoring the safety of herbal medicines.
d) Elaborate Ayurveda system of medicine?

Q3) Solve Any -Three. [15]

a) Explain CCRS in detail.
b) Explain different dosage of ISM.
c) Explain basic principle of Naturotherapy practice.
d) Explain AYUSH in detail.

Q4) Attempt any one question of following. [15]

a) Explain Good manufacturing practice of Indian system of medicine.
b) Describe shelf life and stability studies of ISM formulation.

[6282]-227 1 P.T.O.
Q5) Write a short note on any three. [15]

a) GLP

b) What is Gunapadam. Explain in detail.

c) Elaborate raw drugs in Siddha system of medicine.

d) Explain Asanas and Pranayama in detail.

e) Explain Preparation techique as per Unani Pharmacopeia.



[6282]-227 2
Total No. of Questions : 5] SEAT No. :
PB4689 [6282]-228 [Total No. of Pages : 2

First Year [Link].

MPH203T : COMPUTER AIDED DRUG DEVELOPMENT
( 2019 credit Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Answer in details (Any 1 out of 2) [1×15=15]

a) Discuss optimization. Explain full factorial design in details.

b) Explain in detail concept of Quality by Design. Add a note on ICH Q8
(R2).

Q2) Answer the following (Any 2 out of 4) [2×7½=15]

a) Explain in detail nucleoside transporter OCT and OATP.

b) Write a note on population modeling

c) Explain the concept of IVIVC

d) Write a detail account on AI and robotics.

Q3) Answer the following (Any 3 out of 5) [3×5=15]

a) Define Quality, Quality by Design (QbD) and Quality Target Product

Profile (QTPP).

b) Write a short note on BBB choline transporter.

c) Explain BCRP and hPEPTI.

d) Write a note on comparison between descriptive and mechanistic models.

e) Explain in detail computer simulation in whole organism.

[6282]-228 1 P.T.O.
Q4) Anwer in details (Any 1 out of 2) [1×15=15]

a) Write the significance of In-vitro-In vivo correlation in biopharmaceutical

characterization.

b) Write in detail about biophamaceutical characterization. Explain ACAT

model in details

Q5) Anwer in details (Any 3 out of 5) [3×5=15]

a) Compare descriptive and mechanistic models.

b) Write short note on Use of computers in Marketing Analysis.

c) What are robotics give its applications.

d) Write a short note on Legal Protection of Innovative Uses of Computers

in R &D.

e) Compare population and non-population.



[6282]-228 2
Total No. of Questions : 5] SEAT No. :
PB4690 [6282]-229
[Total No. of Pages :2

First Year M. Pharmacy

MPL 203 T : PRINCIPLES OF DRUG DISCOVERY
(Credit 2019 Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory and carry equal marks.
2) Figures to the right indicate full marks.

Q1) Long answer question. [15]

a) Explain target identification and validation in drug discovery process.

Add note on role of transgenic animals in target validation.

OR

b) Explain G-protein coupled receptor (GPCRs). Note on Pharmacophore

based screening.

Q2) Medium length answers Solve any two. [2×7½=15]

a) What is QSAR? Give advantages and disadvantages of QSAR.

b) Discuss in detail pharmaceutical and pharmacokinetic applications of

Prodrugs.

c) Write in brief account on types of regression with equations.

d) Explain in detail the structure-based drug design.

Q3) Short answer questions Solve any Three. [3×5=15]

a) What are the detection methods used in HTS? Explain in detail.

b) Differentiate between combinatorial synthesis and traditional synthesis.

c) What is parallel synthesis? Explain in detail.

d) Discuss how drug targets are assessed for safety during drug discovery.

e) Give the brief account on the Multivariate Statistical Methods.

[6282]-229 1 P.T.O.
Q4) Long answer question. [15]

a) What are the applications of NMR and X-ray crystallography in protein

structure prediction?

OR
b) What are the various types of docking? Describe in brief.

Q5) Short notes on any Three. [3×5=15]

a) Role of Enzyme inhibition in Drug Discovery Process.

b) Write a note on prediction of protein structure.

c) Write a note on ELISA.

d) Role of bioinformatics in Target Identification.

e) Add a note on in silico lead discovery technique.



[6282]-229 2
Total No. of Questions : 5] SEAT No. :

PB-4691 [Total No. of Pages : 2

[6282]-230
[Link]
MQA - 203T : AUDITS AND REGULATORY COMPLIANCE
(2019 Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on the question paper except seat number.

Q1) Explain elements of quality system model approach for the manufacture of
pharmaceutical products as per USFDA in detail. [15]
OR
Discuss the importance of audits in pharmaceutical industry? Discuss the
types of audits along with their objectives. Give detailed account on
responsibilities of an auditor.

Q2) Attempt any two : [15]

a) Discuss process audit & product audit
b) Discuss steps in audit planning process
c) Give a brief overview of Management responsibilities during a regulatory
audit
d) Write note on audit report

Q3) Attempt any Three : [15]

a) Discuss in detail about functions of quality assurance
b) Write a note on packaging material vendor audit
c) What is the purpose of effluent treatment plant? Discuss its auditing
process.
d) What are goals of auditing packaging material vendors?
e) Explain the auditing of HCG capsule filling line?

P.T.O.
Q4) Explain in detail the cleaning and disinfection method used in microbiological
laboratory? Give a detailed account of auditing these systems. [15]
OR
Give a detailed account of quality assurance audit of HVAC, water, and water
for injections.?

Q5) Write short notes on (any three) : [15]

a) Auditing procedure of a supplier of API
b) Third party audit
c) Classify and discuss the deficiencies in Audits
d) Auditing of warehouse
e) Role of regulatory audits in pharmaceutical industry.



[6282]-230 2
Total No. of Questions : 5] SEAT No. :

PB-4692 [Total No. of Pages : 2

[6282]-231
[Link]
MRA - 203T : REGULATORY ASPECTS OF MEDICAL
DEVICES
(2019 Pattern) (Semester - II)

Time : 3 Hours] [Max. Marks : 75

Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on the question paper except seat number.

Q1) a) Write in details classification, regulatory approval process for medical

devices as per USA regulations. [15]
OR
b) Explain in detail history of medical device regulation

Q2) Attempt any two. [15]

a) Write a note on essential principles of medical devices.
b) Explain the summary technical document of medical devices
c) Write in details about good clinical practice for clinical investigation of
medical devices.

Q3) Attempt any three. [15]

a) Write a note on adverse event reporting of medical device.
b) Clinical evaluation and investigation of medical device
c) Write a note on quality risk management of medical devices
d) Write a note on labeling requirements as per 21CFR part 801

P.T.O.
Q4) Explain in detail quality system regulations of medical devices. [15]
OR
Explain in detail introduction, classification, regulatory approval process for
medical devices as per European Union.

Q5) Write note on three. [15]

a) Write a note on unique device identification (UDI) in medical devices.
b) Write down differences between medical Devices and pharmaceutical.
c) What are the premarket notification, pre-market approval.
d) Explain process of IMDRF study groups and guidance documents.
e) Write a note product lifecycle of medical devices.



[6282]-231 2
Total No. of Questions : 5] SEAT No. :
PB4693 [Total No. of Pages : 2
[6282]-232
First Year M. Pharmacy
MPB-204T : BIOLOGICAL EVALUATION OF DRUG THERAPY
(2019 Credit Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All Questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Define ED50 and LD50. Explain methods to determine LD50. [15]
OR
Define biologic medicines. Explain in detail the role of biologic medicine in
autoimmune disorders.

Q2) Attempt Any Two [15]

a) Method of residuals for determination of Ka.
b) Discuss preclinical investigations of the safety, immunogenicity, and
efficacy of vaccines.
c) What are the contents of ‘New Drug Application’?
d) Describe assay of antibiotics.

Q3) Answer any three : [15]

a) What is ‘LAL’ test?
b) Explain the tests for teratogenicity and mutagenecity.
c) Write on antisense therapeutics.
d) Write on phases of clinical research.
e) What are the measures of bioavailability?

P.T.O.
Q4) Describe standardization of enzyme immunoassay. [15]

OR

Write on regulatory aspects of BA/BE studies for conventional dosage forms

and controlled drug delivery systems.

Q5) Write notes on any three : [15]

a) Monoclonal antibodies.

b) Non compartrnent modeling.

c) Interpretation and significance of bioequivalence study.

d) Pyrogens.

e) Wagner-Nelson method.



[6282]-232 2
Total No. of Questions : 5] SEAT No. :
PB4694 [Total No. of Pages : 2
[6282]-233
First Year M. Pharm. (Pharmaceutical Chemistry)
MPC-204T : PHARMACEUTICAL PROCESS CHEMISTRY
(2019 Credit Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All Questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on the question paper.

Q1) Discuss elaborately about in process control and validation of large scale
process. [15]
OR
Define fermentation. Discuss about aerobic and anaerobic fermentation. Describe
the detailed production of penicillin.

Q2) Attempt Any Two [15]

a) Discuss in detail the principle and general methods of preparation of
polymorphs.
b) What do you mean by industrial safety? Write a detailed note on
OHSAS-1800.
c) Comment on impurities in Active Pharmaceutical Ingredients (sources
and types including genotoxic impurities).
d) Write in detail about filtration, theory and types.

Q3) Attempt Any Three [15]

a) Explain H2O2 and sodium hypochlorate as oxidizing agents. Give suitable
examples.
b) Explain counter current extraction.
c) Discuss streamlining reaction steps and route selection.
d) Discuss about effluents and management system in industries.
e) Define evaporation. Enlist and explain factors affecting evaporation.

P.T.O.
Q4) Enlist various unit operations. Define distillation. Explain azeotropic and steam
distillation methods with suitable examples. [15]

OR

Elaborate in detail about nitrating agents, aromatic nitration with kinetics and
mechanism and mixed acid for nitration.

Q5) Write short notes on (Any Three) : [15]

a) Fire hazards and types of fire extinguishers.

b) Hazard labels of chemicals and Personal Protection Equipment (PPE).

c) Catalytic hydrogenation.

d) Kinetics of halogenation.

e) Counter current extraction.

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Total No. of Questions : 5] SEAT No. :
PB4695 [Total No. of Pages : 2
[6282]-234
First Year [Link] (Pharmacognosy)
MPG-204T : HERBAL COSMETICS
(2019 Credit Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Draw well labelled diagrams wherever necessary.
3) Figures to the right indicate full marks.

Q1) Explain import and export of herbal cosmetics. [15]

OR
Discuss method of preparation and standardization of dentifrices and mouth
washes.

Q2) Answer the following (Any two) [15]

a) Explain toxicity of cosmetics.
b) Write in detail about chemistry of hairs.
c) Elaborate on design of herbal cosmetic formulation.
d) What is moisturizing cream? Write method of preparation of moisurizing
cream.

Q3) Solve any three [15]

a) Give classification of herbal cosmetics.
b) Write about physiology of face powder.
c) Discuss method of preparation of hair oil.
d) Explain preparation method of vanishing cream.
e) Describe preformulation studios of herbal cosmetics.

P.T.O.
Q4) Attempt any one question of following : [15]

a) Explain raw material, preservatives & surfactants used in herbal cosmetics.

b) Describe different quality control methods of herbal cosmetics.

Q5) Write a short note on any three. [15]

a) Herbal lipstick.

b) Economic aspects of natural cosmetics.

c) Herbal deodorants.

d) Compatibility studies.

e) Herbal cleansing cream.

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Total No. of Questions : 5] SEAT No. :
PB4696 [Total No. of Pages : 2
[6282]-235
First Year [Link]
PHARMACEUTICS
MPH-204T : Cosmetic and Cosmeceuticals
(2019 Credit Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.
3) Draw well labeled diagrams wherever necessary.
4) Do not write anything on question paper except seat number.

Q1) Define cosmetics and explain the regulatory requirements for labeling of
cosmetics in India. Add a note on provisions related to the import of cosmetics.
[15]
OR
Define lipsticks. Write in detail about formulation and evaluation of lipsticks.

Q2) Attempt Any Two [15]

a) Discuss in detail about herbal agents used to prepare herbal hair care
products.
b) COSMOS guidelines for controversial ingredients.
c) Classification of cosmetics based on their use. Provide example of each
category.
d) Explain tanning and remedies used to prevent tanning.

Q3) Attempt Any Three [15]

a) Loan licence and third party manufacturing of cosmetics
b) Rheological additives and their application in cosmetics
c) Explain the formulation development of toothpaste.
d) Explain nail lacquer base formulation.
e) Deodorants

P.T.O.
Q4) Define cream. Explain various types of creams along with giving the building
blocks for formulating them. Add a note on evaluation parameters of creams.[15]

OR

Explain the structure arid functions of hair. Describe formulation of hair

colourants.

Q5) Write short note on (Any three) : [15]

a) Discuss about controversies related to parabens and formaldehyde

liberators.

b) Sun protection factor.

c) Discuss the perfume ingredients listed as allergens in EU regulations.

d) Compare traditional soaps with syndet bars. Give merits and demerit of
using syndet bars in cosmetics.

e) Mouthwashes.

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Total No. of Questions : 5] SEAT No. :

PB-4697 [Total No. of Pages : 2

[6282]-236
[Link]
MPL - 204T : Clinical Research and Pharmacovigilance
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory and carry equal marks.
2) Figures to the right indicates full marks.

Q1) Long answer questions : [15]

a) Define ADRs. Explain “type B” ADRs with two examples.
OR
b) Explain ICH - GCP Guidelines. Add a note on importance of phase III
clinical trial.

Q2) Medium length answers (Solve any two) : [2 × 7½ = 15]

a) Schedule Y.
b) Phase II clinical trial.
c) Note on International classification of disease.
d) Importance of safety monitoring in PVS.

Q3) Solve any Three [3 × 5 = 15]

a) CRO.
b) Adverse events with examples.
c) ICMR in clinical trail study.
d) Responsibilities of IRBs.
e) Phase I clinical trial.

P.T.O.
Q4) Long answer question : [1 × 15 = 15]

a) Explain History, progress and current advances of pharmacovigilance

with one example.

OR

b) Write is clinical trial protocol. Explain in detail. Clinical research study.

Q5) Short notes (Any three) : [3 × 5 = 15]

a) Sponsor’s in clinical trial.

b) Clinical research Associate.

c) Reporting of ADRs.

d) Informed consent for clinical trial study.

e) Pharmaco economics.

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Total No. of Questions : 5] SEAT No. :

PB-4698 [Total No. of Pages : 2

[6282]-237
[Link] (Pharmaceutical Quality Assurance)
MQA - 204T : Pharmaceutical Manufacturing Technology
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Explain in detail the problem encountered in coating technology. [15]

OR

What is in process quality control tests for tablets and capsules?

Q2) Attempt any two : [15]

a) Describe materials used for making containers.

b) Explain QbD for Excipients

c) Explain Form Fill Seal Technology (FFS)

d) Explain IPQC test for Suspension and Emulsion

Q3) Attempt any three : [15]

a) Discuss key elements of QbD. What are advantages of QbD

b) Comment on ‘Overall review of Production planning”.

c) Explain Rapid mixing granulator and Rota granulators

d) Explain quality control of packaging material

e) CIP and SIP

P.T.O.
Q4) Describe layout of sterile and aseptic area for manufacturing of parental product.
[15]

OR

Discuss on “PAT as a driver for improving quality and reducing costs”. Add
details on standards and regulatory requirements.

Q5) Write short note on any three : [15]

a) Factors influencing plant location and layout.

b) Glass containers and types.

c) QTPP and CQA.

d) Spheronizers and Pellitization.

e) Closures.

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[6282]-237 2
Total No. of Questions : 5] SEAT No. :

PB-4699 [Total No. of Pages : 2

[6282]-238
First Year [Link]
MRA - 204T : Regulatory Aspects of Food & Nutraceuticals
(2019 Pattern) (Semester - II)
Time : 3 Hours] [Max. Marks : 75
Instructions to the candidates:
1) All questions are compulsory.
2) Figures to the right indicate full marks.

Q1) Long answer questions (Any 1) : [1 × 15 = 15]

a) Describe about the regulations aspects for import & manufacture of

nutraceuticals products in India.

b) Explain in details about the services of NSF in dietary supplement and

nutraceuticals.

Q2) Medium length answers (Any 2) : [2 × 7½ = 15]

a) What is Nutraceuticals? Give various categories of Nutraceuticals with

example.

b) Give details about Recommended Dietary Allowances (RDA) in India.

c) Explain European Regulation on novel food ingredient.

d) What is food safety and standard act? Give its composition along with
their role.

Q3) Short Answer (Any 3) : [3 × 5 = 15]

a) Describe about Recommended Dietary Allowance in Europe.

b) Give details about responsibilities of USFDA.

P.T.O.
 c) Occurrence and management of disease due to lack of micronutrients.

d) What is nutraceuticals? Classify them explain any two.

e) Give the importance of confirmation of supplements by health care

professional.

Q4) Long answer questions (Any 1) : [1 × 15 = 15]

a) Explain in detail Good Manufacturing Practices for Nutraceuticals.

b) Write note on NFS standards for food dietary supplements.

Q5) Short notes (Any 3) : [3 × 5 = 15]

a) European Nutrition labeling requirements.

b) Role of Probiotics in management of disease.

c) Recommended Dietary Allowances (RDA) in the U.S.

d) Scope and Opportunities in Nutraceuticals Market.

e) WHO guidelines on nutrition.

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