Dr. Parjanya Shukia Dr.
Parfenga &hdlg
Dr. M. 9. Singh Claac
Thdustrial Phamay - Unit-3 BP702T
Dr. M. P. Slngh Claae
Requlatory Reguirements for Drug Apbrova!
’ Non-ClinicalDrug Development i
* Non-Clinical Drug Develobment refers to the second phase of the
drug development þrocess.
* It þrimarily involves þreclinical studies that are crucia! for
understanding the safety and efficacy of a new drug before it enters
human clinical trials.
* These studies are tybically conducted in -vitro (out side the Living
organism)and in-vivo (using animal models).
*Non-clinical drug develo þment ivolves several key
1. Preclinical Studies. -
Pharmacology: Understanding the drug's mechanism of action, its
effects on the body, and its therapeutic þotentia!.
Toxicokogy: Asscssing the potential harmful effects of the drug
including acute, ub-chronic, and chronic toxicity, genotoxicity.
carcinogenicity,rebroductive toxicity, and organ-sþecific toxicity.
Pharmacokinetics : Studying the absovption, distvibution, metabolism,
and excretion(ADME)of the drug.
Pharmacodynamica : Investigatig the drug's biologica! effects,
including the dose-resbonse relationhip and therapeutic window.
By- Dr.Mahu ndra Aratab Singh
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Dr. fafangya huhde
Dr. Parjangya Shutia
Dr. M. 9. ng CaMA
Br. N.P. Singh Cas
Drug Formulation: Develobing stable formulations that ensUYe the
drug's optimal delivery, stability, and bioavailability.
Exciþienta and Delvery Syatens: Identifying abpropriate excibienta
inactive ingredients that enhance the drugs dekiycry and therabeutic
effectivene 88.
2. Good Laboratory Practices(GLP):
* GLP guideline& en&ure that þreclinical studies are carried out under
consistent and scientifically s8Ound conditions, focusing on safety
reliability.
Compliance with GLP is essential for regulatory submission.
3. Regulatory Afaira:
Investigationa! New Drug IND Abþlication. Before moving to clinical
trials, drug developers must submit an IND abþlication to regulatory
agenciea.
*TAis includes data from non-cliica! studie3, 81fety information, and
þlans for human clinical trials.
By-Dy. Mahu ndro Pratas Singh
4. Aninal Studieg
Safety Pharmacology: Animal studies evaluate potential riaks related
to the cardiov ascular,resbiratory, and centralnerv ous kyatens.
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Br, Paufanya Shula Dr. Parfanya huhla
&
Dr. V. P. Singh Claasca Dr. M. P. SUngh Clasm
Dosing Studies: Determining the safe and cffective doscA in animals
before þrog ressing to human triala.
5.Bioanalytical Methodsi
Develoþment and validation of ana lytica! techniques for quantifying
drug concentvations in biological matrices e.g, þlasma, tissues.
Techniques ike HPLC, LC-MS/MS are commonly used.
6. Stability Studies -
Testing how the drug's active ingredients and its formu lation maintain
their properties over time under different conditions e.g., temberature,
humidity, light.
7.Pharmaceutical Develohment: -
Drug Design: 0ptimization of the suitable dozage form of the drug to
enhance efficacy and minimize side effects.
Process Develoþment: Scaling up the manufacturing þrocess from
laboratory scale to comnercial þroduction, ensuring consistency and
quality.
By-Dr, Mohundra Pratap Singb
8. Safety Assesament:
Ensuring that the drug is not only effective but also safe for Auman
Lse by studying þossible adverse cfects and defining maximum
tolerated doses.
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Dr. W.9. Singh Clas Dr. M. P. Slngh Claase
9. Non-Clinica! Datafor IND Submission:
* The non-clinica! data gathered is crucial for the IND submission
þrocesa.
* It inckudes al! the studies that supþort the safety þrofile of the
drug and justiBy its transition to human clinical trials.
10. Challenges in Non-clinical Drug Develoþment:
Shecies Di{ferences.: Animal models may not always bredict human
resþonse accurately.
Ethica! Considerations: There are grouing concerns and requlations
BurrOunding the use of animals in drug development.
Cost and Tinc: Non-ckinical studies can be time consuming and cxpensive.
oftenreguiring several yearsbefore reaching clinical trial readiness.
By-Dr Mahundro Aratab Singh
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