JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy IV Year PHARMACEUTICAL REGULATORY SCIENCE Previous Question Paper (June/July - 2024 - 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
Write down the difference between innovator and generics.
Answer
An innovator drug is a new chemical entity protected by a patent, developed after extensive research and clinical trials. A generic drug is a pharmaceutical product designed to be bioequivalent to the innovator drug in dosage, strength, route of administration, and quality, usually marketed after the innovator's patent expires.
Write a note on IRB.
Answer
An Institutional Review Board (IRB), also known as an Independent Ethics Committee, is an independent body consisting of medical, scientific, and non-scientific members. Its primary responsibility is to protect the rights, safety, and well-being of human subjects participating in clinical trials by reviewing and approving study protocols, informed consent documents, and investigator qualifications before the trial begins.
What are pre-clinical studies?
Answer
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What is ACTD?
Answer
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What are the advantages of ACTD?
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Write about the safety monitoring of medical products.
Answer
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What is the importance of investigator’s brochure?
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Write about the approaches of 21 CFR part 11.
Answer
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What is informed consent process?
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What are clinical trials?
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Part B
Define new drug according to FDA. Explain in detail the new drug development process with the time course for each phase.
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Explain different stages of drug discovery.
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Explain the organization and functions of Australia and US drug regulatory bodies.
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Explain the application and regulatory approval process for IND.
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What are open and closed part of DMF. Explain in detail on DMF system in India.
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What is Common Technical Document? Describe various CTD modules.
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Discuss different stages of clinical studies.
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How can be clinical trials managed and monitored. Explain the development of clinical trial protocols.
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Explain the code of federal regulation. Write a note on federal register.
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Explain in detail about orange book and purple book.
Answer
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