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Work Plan

The document outlines the development and validation of analytical and bioanalytical methods for selected classification drugs using UV spectroscopy, HPTLC, and HPLC-MS/MS, with a focus on pharmacokinetics. It details a five-phase work plan that includes literature review, method optimization, validation, application to pharmacokinetics, and thesis writing. The study will involve a selection of 4 to 6 new drugs based on their availability.

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Satish Kumar
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18 views2 pages

Work Plan

The document outlines the development and validation of analytical and bioanalytical methods for selected classification drugs using UV spectroscopy, HPTLC, and HPLC-MS/MS, with a focus on pharmacokinetics. It details a five-phase work plan that includes literature review, method optimization, validation, application to pharmacokinetics, and thesis writing. The study will involve a selection of 4 to 6 new drugs based on their availability.

Uploaded by

Satish Kumar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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TITLE

ANALYTICAL AND BIOANALYTICAL METHOD DEVELOPMENT AND


VALIDATION OF SELECTED CLASSIFICATION DRUGS BY UV SPECTROSCOPIC,
HPTLC, HPLC-MS/MS AND ITS APPLICATION TO PHARMACOKINETIC (BIO-
PHARMACEUTICS)

UV SPECTROSCOPIC:(Analytical)

i) Method development and validation


ii) Zero order derivative spectroscopy
iii) First order derivative spectroscopy
iv) Second order derivative spectroscopy

HPTLC: (Analytical & Bioanalytical)

i) Method development and validation

HPLC-MS/MS: (Analytical & Bioanalytical)


i) Method development and validation
ii) Application part (pharmaceutics dept related as we discussed)

iii) Bio-pharmaceutics
TDM
iv) b) Bioavailability and bio-equivalency testing: dosage forms,
dissolution rate and bio-equivalency testing.
v) Bio-statistics

DRUGS SELECTION:

i) Maximun 6 drugs
ii) Minimun 4 drugs
Drugs class have to select based on new drugs availability
Methodology/Work Plan
The work plan of study will be divided into five phases

Methodology/Work Plan
35

Phase 5
Duration of Activity (Months)

30

25 Phase 4

20 Phase 3

15
Phase 2
10 Phase 1

Activity.

Phase One: Literature survey and selection of drugs.


Literature will be collected through the available books, journals and web sources. Systemic
survey of the drug category, mechanism of action, therapeutic effects, its absorption, distribution,
metabolism and excretion will be checked
Phase Two: Method development and optimization of chromatographic condition & extraction
procedure in biological fluids.
Phase Three: Validate the method as per the USFDA and ICH guidelines.
Phase Four: Application of the validated method to establish the pharmacokinetic parameters of
individual & combination of drugs in humans.
Phase Five: Conclusion and thesis writing.
Based on the data evaluation, conclusions will be made in congruence with the supervisor. The
details of study designs, data, results and discussions along with the final conclusions will be
written in thesis format. The thesis will be submitted to concerned authorities after completing
the PhD seminar presentation.

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