JNTU
JNTU B.Pharmacy IV PHARMACEUTICAL REGULATORY SCIENCE Previous Question Paper (December – 2023/ January -2024 - R17)
Part A is compulsory which carries 25 marks. Answer all questions in Part A. Part B consists of 5 Units. Answer any one full question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Define Innovator and Generic Drugs.
Answer
An Innovator drug is a new chemical entity that has been developed, patented, and approved by regulatory authorities based on original clinical research. A Generic Drug is a pharmaceutical product designed to be bioequivalent to an innovator drug in dosage form, strength, route of administration, and intended use, typically marketed after the innovator's patent expires.
Why pre-clinical studies are carried out? Write purposes of the same.
Answer
Pre-clinical studies are conducted to assess the safety and biological activity of a drug candidate before human exposure. The primary purposes include: 1) Determining the pharmacological profile and mechanism of action; 2) Evaluating toxicological effects, including acute, sub-chronic, and chronic toxicity; and 3) Establishing the initial safe starting dose for human clinical trials.
What is meant by ANDA? How is it useful to pharma companies?
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Write about types of INDs approved by USFDA.
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Enlist documents required while exporting pharmaceutical products.
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Provide importance of DMF and CTD.
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Outline purpose of Institutional Review Board.
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Recall importance of informed consent in clinical trials.
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Expand the term CFR. Pharmaceutical legislations in the US are included under which title of CFR.
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Tell the objectives of Guidance Documents by USFDA. List a few guidance documents.
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Part B
Examine the drug approval process in India, US and Europe with a brief note on their regulatory agencies.
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Analyze lead identification, lead optimization, target identification and target validation as a part of drug discovery process. Organize steps involved in drug development.
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Illustrate and explain four different pathways to get a Marketing Authorization for pharmaceutical products in European Union.
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Explain IND and NDA approval process.
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Categorize various modules of CTD with their explanation. How is ASEAN CTD (ACTD) different from CTD?
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Summarize procedure for export of pharmaceutical products from India. List agency/council that facilitates exports of such products in the country.
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Define pharmacovigilance and summarize pharmacovigilance activities. Write a short note on Pharmacovigilance Program of India (PvPI) and Periodic Safety Update Reports (PSUR).
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Identify processes involved in Clinical Trial Management, Monitoring aspects and site management.
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Differentiate the terms Legislations, Regulation and Guideline. Highlight the role of “Orange book” and how it helps generic drug manufacturers.
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Apprise the importance of guidance documents by regulatory agencies for pharmaceutical companies during drug discovery and approval.
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