JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B. Pharmacy IV PHARMACEUTICAL REGULATORY SCIENCE Previous Question Paper (July - 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
Define clinical development phase in drug discovery.
Answer
The clinical development phase refers to the series of human trials conducted after successful preclinical testing to evaluate the safety, efficacy, and therapeutic dosage of a new drug candidate before it is approved for marketing.
Define new drug as per CDSCO.
Answer
As per CDSCO, a new drug is defined as a drug, including active pharmaceutical ingredients or fixed-dose combinations, that has not been approved by the Licensing Authority in any therapeutic category or has been approved but is proposed to be marketed with modified claims, new dosage forms, or new routes of administration.
Define NDA.
Answer
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Explain the scope of para 2 in ANDA submission.
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Define CTD.
Answer
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What are the advantages of ACTD?
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What is safety monitoring in clinical trials?
Answer
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Explain the scope of monitors in clinical trials.
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What is Orange Book?
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Explain the importance of Purple Book.
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Part B
Discuss in detail about regulatory overview of Phase III clinical trial.
Answer
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Discuss in detail about clinical development stages.
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Explain the steps involved in NDA.
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Discuss in detail about overview of regulatory authorities of European Union.
Answer
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An Indian company plans to export anti-viral drug to US, what are procedures must be followed as per the regulatory requirement.
Answer
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Discuss in detail about ACTD.
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Discuss in detail about informed consent process and procedures.
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Discuss in detail about pharmacovigilance and its importance in conducting clinical trials.
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Explain in detail about various guidelines and regulation, its importance in regulatory concept.
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Explain the scope of laws and acts and federal register and its importance.
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