How to Discover New Drug and development? Explain Stages of drug discovery.
[6 marks]Explain Regulatory Concepts of Purple book.
[5 marks]Write a note Investigator’s Brochure (IB)?
[5 marks]Explain Approval processes and timelines involved in Investigational New Drug (IND).
[6 marks]Explain review process for New Drug Application (NDA).
[5 marks]Write a note on ANDA.
[5 marks]Write a note on Quality by Design (QbD).
[6 marks]Explain Regulatory requirements of EU.
[5 marks]Write a note on MHRA.
[5 marks]Define CTD & e CTD. Explain modules of CTD.
[6 marks]What is DMF? Write a short note on Type of DMF.
[5 marks]How to develop Generic drug product? Explain in brief.
[5 marks]Explain Procedure for export of pharmaceutical products.
[6 marks]Explain ASEAN Common Technical Document (ACTD) research.
[5 marks]Explain pre-clinical studies & non- clinical activities for New drug discovery. Q. 6 (a) How to Developing clinical trial protocols? Explain in brief.
[6 marks]Explain Pharmacovigilance & safety monitoring in clinical trial.
[5 marks]Explain the scope of TGA regulations.
[5 marks]Explain CFR 21(code of federal regulation).
[6 marks]Define ‘Orange Book’, ‘Green Book’ and ‘Blue Book’. Explain statistical criteria for Bio-equivalence in context to orange book.
[5 marks]Write a note on ANDA. Explain the concept of PARA Ito IV filling.
[5 marks]