Discuss and differentiate innovator and generic drugs.
[5 marks]Explain in detail about new drug development process with the time course of each phase.
[6 marks]Discuss about various stages of drug discovery.
[5 marks]Discuss about organization structure and overview of regulatory authority of India.
[6 marks]Describe general consideration and content of NDA.
[5 marks]Define IND. Discuss various types of IND.
[5 marks]Write a note on Preclinical studies.
[5 marks]Discuss on TGA.
[5 marks]Describe how Waxman-Hatch Act has simplified and facilitated approval of generic products in US?
[6 marks]Discuss composition and importance of Informed consent.
[5 marks]What is IRB? Discuss composition and functions of IRB.
[6 marks]Write a note on- Orange book.
[5 marks]What is Common Technical Document? Describe various CTD modules.
[6 marks]Give in details of Pharmacovigilance safety monitoring in Clinical trials.
[5 marks]Write a note on Code of Federal Regulations.
[5 marks]Define- Investigator, Sponsor and Monitor. Explain functions and responsibilities of sponsor.
[6 marks]Write a note on Good Clinical Practice.
[5 marks]Write a note on Purple book.
[5 marks]What is the importance of investigator’s brochure? Give a brief outline of clinical research protocols.
[6 marks]What is DMF? Discuss types of DMF.
[5 marks]Discuss procedure for export of pharmaceutical products. Page 1 of Page 2 of
[2 marks]