Explain in detail about IND application.
[6 marks]Brief about pre-clinical evaluation of drug during development process.
[4 marks]Define ICF. Discuss designing of Informed consent form.
[4 marks]Make a detail note on the designing of the protocol for clinical study.
[6 marks]Brief role and responsibilities of followings (A) Regulatory authority (B) Investigators
[4 marks]Short note on various phases of clinical trials.
[4 marks]Define Sponsor. Explain sponsor’s responsibilities.
[6 marks]Discuss ethical guideline requirements during clinical research.
[4 marks]Define Toxicity. Brief about toxicological studies conducted during drug development process.
[4 marks]Discuss ICH-GCP guideline in accordance with good clinical practice.
[6 marks]Brief on the role and responsibilities of the Auditors during clinical studies.
[4 marks]Explain in detail about Informed Consent Process.
[4 marks]Discuss the process of ANDA submission.
[6 marks]Brief about methods of the post marketing surveillance.
[4 marks]Make a note on role and responsibilities of the clinical research coordinator. Q. 6 (a) Brief the composition of IRB. Explain in details about responsibilities of members.
[6 marks]Describe the procedure of the IEC for the approval of the protocol.
[4 marks]Define CRF. Explain in detail about its designing.
[4 marks]Compare and overview of regulatory requirements in USA, Europe and India.
[6 marks]Discuss challenges in the implementation of the different guidelines.
[4 marks]Define followings: Dosage form, Drug Characterization
[4 marks]