Explain the regulatory approval process for ANDA.
[6 marks]Enlist different drug regulatory body in India. Explain any one from them.
[5 marks]Write a note on Preclinical studies as per CDSCO.
[5 marks]What is CTD and eCTD. Explain the different modules of CTD in detail
[6 marks]Discuss the criteria for selection of human volunteers in clinical trials.
[5 marks]Differentiate innovator and generic products.
[5 marks]What is IRB? Describe working and functions of IRB.
[6 marks]Explain the regulatory approval process for New Drug Application.
[5 marks]Explain in detail about Orange Book.
[5 marks]Explain the organization and functions of CDSCO.
[6 marks]Write a detailed note on Generic Drug Development.
[5 marks]Explain the salient features of pharmacovigilance.
[5 marks]Define clinical trial and explain Phase III.
[6 marks]Explain code of federal regulation.
[5 marks]Write different modules of ACTD. Q. 6 (a) Explain regulatory change over from NDA to ANDA.
[6 marks]Explain salient features of Purple Book.
[5 marks]Explain code for federal regulation with respect to Part 21.
[5 marks]What is DMF? Explain the different contents of DMF.
[6 marks]Explain the organization structure and functions of Australian drug regulatory body.
[5 marks]Write a detailed note on Technical Documentation.
[5 marks]