JNTU
JNTU B.Pharmacy IV PHARMACEUTICAL REGULATORY SCIENCE Previous Question Paper (January/February - 2023 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, Answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
Enlist the stages of drug development process.
Answer
- Drug Discovery
- Pre-clinical development
- Clinical development (Phase I, II, III)
- Regulatory review and approval
- Post-marketing surveillance (Phase IV)
Differentiate innovator and generic products.
Answer
| Feature | Innovator Product | Generic Product |
|---|---|---|
| Development | Developed by the original manufacturer with full clinical data. | Developed as a bioequivalent copy of the innovator. |
| Cost | Higher due to R&D and clinical trial expenses. | Lower as clinical trials are not repeated. |
| Approval | Requires New Drug Application (NDA). | Requires Abbreviated New Drug Application (ANDA). |
Write the Functions of US regulatory authority.
Answer
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Difference between NDA and ANDA.
Answer
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Write about Salient features of DMF.
Answer
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Write note on Module III in eCTD.
Answer
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Exclusion criteria in clinical trials.
Answer
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Explain the Process of informed consent.
Answer
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Mention Salient features of purple book.
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Write a note on Federal register.
Answer
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Part B
Describe the contents of investigator brochure used in clinical studies.
Answer
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Explain the stages of drug discovery process.
Answer
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Discuss the various stages involved in generic product development.
Answer
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Enumerate the process involved in shifting from NDA to ANDA.
Answer
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Describe the regulatory approval process for ANDA.
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Explain organization structure of Europe drug regulatory authority.
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Describe regulatory approval process of IND.
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Enumerate the process of DMF system.
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Discuss the procedure for the export of the pharmaceutical products.
Answer
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Explain the different modules of CTD in detail.
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Discuss the salient features and importance of Pharmacovigilance.
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Explain the constitution and functions of Institutional Review Board.
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Explain the development of clinical trial protocols.
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Write a note on monitoring of clinical trials.
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Explains different laws involves in regulatory concepts.
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Write about guidelines of regulatory concepts.
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Explain code for federal regulation with respect to Part 21.
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Describe the salient features and importance of orange book.
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