Explain generic drug product development in detail.
[6 marks]Write a note on clinical studies.
[5 marks]Explain in brief ANDA.
[5 marks]Give overview of regulatory authorities of United States.
[6 marks]Discuss in detail about IND.
[5 marks]Briefly discuss CTD and eCTD.
[5 marks]Discuss Procedure for export of pharmaceutical products.
[6 marks]Write a note on ACTD
[5 marks]Discuss in brief DMF.
[5 marks]Discuss the procedure to develop clinical trial protocols.
[6 marks]Give overview of regulatory authorities of Japan.
[5 marks]Write a note on IRB.
[5 marks]Write about Informed consent process.
[6 marks]Discuss about Purple book.
[5 marks]Write a note on Code of Federal Regulatory. Q. 6 (a) What is Orange book? Explain.
[6 marks]Discuss about GCP obligations of Investigators, sponsors & Monitors
[5 marks]Explain Pharmacovigilance.
[5 marks]Discuss on TGA.
[6 marks]Write a note on NDA.
[5 marks]Explain in brief pre-clinical studies.
[5 marks]