Discuss the role of pharmacological studies in drug development process.
[6 marks]Compare and contrast of Phase-1 & Phase-2 clinical trials.
[4 marks]Explain the role and responsibilities of clinical research associates in clinical trial studies.
[4 marks]Discuss in detail about CDSCO guidelines.
[6 marks]What is drug discovery? What are the steps involved in the process?
[4 marks]Enlist various methods of PMS study. Discuss the any two methods of PMS study.
[4 marks]Explain the role and responsibilities of investigator in clinical trial studies.
[6 marks]Explain investigator brochure.
[4 marks]Write in detail various components of protocol in clinical trial. Describe the protocol amendments.
[4 marks]Write a note on ANDA requirements.
[6 marks]Write a note on micro dosing clinical trial study.
[4 marks]Explain Data Safety Monitoring Board.
[4 marks]Explain composition and role and responsibilities of IRB/IEC.
[6 marks]Describe the procedure of communicating ADR reports & Periodic Safety Update Reports (PSUR).
[4 marks]Discuss the role of dosage form studies in drug development process. Q. 6 (a) Discuss the purpose of IND, NDA and ANDA.
[6 marks]Write a note on Informed Consent Process.
[4 marks]Give an overview of regulatory environment in USA.
[4 marks]Write in detail about Data storage and security in CDM.
[6 marks]Write a note on compensation for clinical trial subjects as per ethical guideline.
[4 marks]Describe the essential criteria of ICH-GCP guideline for conducting clinical trials.
[4 marks]