Discuss in detail about various phases of drug development.
[6 marks]Discuss briefly about Innovators and Sponsors.
[5 marks]Explain in detail the sources of new drug.
[5 marks]Differentiate INDA and ANDA. Describe various type of INDA.
[6 marks]Explain classification of drugs in NDA. Prepare a NDA chart showing NDA review process.
[5 marks]Explain the concept of paragraph Ito IV and generic exclusivity.
[5 marks]Write a note on clinical studies as per CDSCO.
[6 marks]Explain in detail CTD Vs eCTD. Describe various CTD modules.
[5 marks]What is MHRA? Discuss in brief about approval of new drug by MHRA.
[5 marks]Discuss the pharmacovigilance safety monitoring in clinical trials.
[6 marks]What is Post Marketing Surveillance (PMS)? Give it’s important in clinical trials.
[5 marks]What is the importance of investigator’s brochure? Give a brief outline of clinical research protocols.
[5 marks]Discuss about 21 CFR Part 211 for packaging and labelling requirements of Pharmaceuticals in USA.
[6 marks]What is mean by bioequivalence and explain drug product assessment related to BE.
[5 marks]Discuss the importance of documentation in Pharmaceutical industry. Q. 6 (a) Write a note on Hutch Waxman Act and Amendments for generic drugs.
[6 marks]What is DMF? Write a note on Type of DMF.
[5 marks]Write note on Orange book.
[5 marks]Describe Informed Consent process and procedures for clinical trial study.
[6 marks]Discuss special emphasis on approval under 505 (b) (2).
[5 marks]Describe HIPAA-new requirement to clinical study process.
[5 marks]