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Regulatory Requirements For Drug Approval

The document outlines the regulatory requirements for drug approval, detailing the drug development process which includes phases such as drug discovery, pre-clinical testing, clinical studies, and FDA review. It highlights the roles of various teams involved in drug development, including scientists, toxicologists, and regulatory professionals. Additionally, it discusses non-clinical studies aimed at ensuring drug safety through animal testing and pharmacological profiling.

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2K views7 pages

Regulatory Requirements For Drug Approval

The document outlines the regulatory requirements for drug approval, detailing the drug development process which includes phases such as drug discovery, pre-clinical testing, clinical studies, and FDA review. It highlights the roles of various teams involved in drug development, including scientists, toxicologists, and regulatory professionals. Additionally, it discusses non-clinical studies aimed at ensuring drug safety through animal testing and pharmacological profiling.

Uploaded by

nextuplucifer101
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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REGULATORY REQUIREMENTS

FOR DRUG APPROVAL

[Link], 7th Sem


INDUSTRIAL PHARMACY II
BHARAT PHARMACEUTICAL TECHNOLOGY
Drug Development Team
 Drug development is a process of bringing a
new pharmaceutical drug into the market
after investigation through several phases,
which includes:
 Drug Discovery
 Pre-clinical Testing
 IND application filing
 Clinical Studies (Phase I, II & III)
 NDA filing
 FDA Review & Decision
 Phase IV (Post Marketing)
Drug Development Team
 Discovery & Development Group: Scientists
& Chemists
 Non-clinical Group: Toxicologists &
Pharmacologists.
 Clinical Group: Pharmacologists & Doctors
 Regulatory Group: Regulatory Professionals
 Marketing Group: Marketing Professionals
 Engineering Group: Engineers
 Legal Group: Lawyers
Non Clinical Drug Development
 A targeted drug has to go through several studies
such as non-clinical and clinical phases/studies.
 Non-clinical studies are also known as pre-clinical
studies.
 During this study important safety data's are
collected, which is essential for filing IND application.

 Objective:
 To confirm that the target drug is safe for use in
humans or not. (It is done by studying animal
pharmacology and toxicology testing)
 To determine the LD50, ED50 etc.
 To determine the pharmacokinetics of the drug and
also the route of administration.
Non-Clinical Drug Development
 Non-Clinical Drug Development Process:
 Pharmacological Profile: The compound
identified is subjected to animal testing
which involves 2 stages:
1. EOR (Experiment on Rodents): Mouse, Rats,
Rabbits etc
2. EOLA (Experiment on Larger Animals): Dog,
Cow, Monkey etc

 The compound is administered via oral and


parenteral route to assess its safety.
Non-Clinical Drug
Development
 Types of Non-Clinical studies:
Pharmacodynamics:
o Primary: To determine the effect of the
compound on the target organ.
o Secondary: To determine the effect of the
compound on organs other than the target
organ.
o Safety: To determine the lethal dose and to
check the effect of the compound on CNS,
Cardiovascular and Respiratory system at
therapeutic and higher dose.
Pharmacokinetics: To determine the ADME of
the compound.
THANK YOU

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