MPH-104T

M.Pharmacy (PCI), I Semester

Time: Three Hours

Maximum Marks : 70

Note: i) Attempt any five questions.

ii) All questions carry equal marks.

What is ANDA approval process? Give various regulatory requirement for product approval of biologics.

Write a note on:

Regulation for combination product

Guidelines of ICH-Q, S

What is global submission process for non-clinical development as IND? Explain IMPD in detail.

Elaborate clinical trial protocol and informed consent process.

Discuss regulatory requirements ROW. What are problems faced by CRO in outsourcing BA and BE?

Explain in detail:

Documentation in pharmaceutical industries

Discuss code of federal regulation.

What is HIPAA? Explain its significance in clinical trial.

What are objectives of CDER? Discuss generic drug user fee amendments.