Describe the procedure for new drug approval from CDSCO in India.
[6 marks]Explain Innovator and generics products with suitable example.
[5 marks]What is Post Marketing Surveillance (PMS)? Give it’s important in clinical trials.
[5 marks]Write a note on ANDA. Explain PARA Ito IV filling in ANDA.
[6 marks]Define IND. Discuss about different types of IND.
[5 marks]Write about post approved changes in NDA.
[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]Give details note on MHRA.
[5 marks]Discuss composition and functions of Institutional Review Board.
[6 marks]Discuss components and importance of informed consent form.
[5 marks]Give in details of Pharmacovigilence safety monitoring in Clinical Trials.
[5 marks]Define ‘Orange Book’. Describe the codes for therapeutic equivalence evaluation.
[6 marks]Explain terms: i) CMC ii) Biowaiver iii) Purple Book iv) ACTD v)EMA
[5 marks]What are the clinical trials? How are they organized as a part of drug discovery? Q. 6 (a) Describe general consideration, specific requirements and contents of an NDA.
[6 marks]Write a note on Good Clinical Practices.
[5 marks]Explain the various components of FDA.
[5 marks]Discuss about clinical research Protocols.
[6 marks]Give organization structure, activities and responsibilities of TGA.
[5 marks]Describe various activity regulated by CDER.
[5 marks]