Discuss pre-clinical drug discovery process
[6 marks]Briefly describe the various phases of clinical trials
[4 marks]Describe responsibilities of data and safety monitoring board
[4 marks]Write roles and responsibilities of study investigator in clinical study team
[6 marks]Which type of preclinical information should be included in a IND application.
[4 marks]Write a brief note on Investigator’s brochure.
[4 marks]Write the safety issues on the investigational new drugs
[6 marks]Write important aspects of clinical study protocol preparation
[4 marks]Write a short note on clinical trial protocol
[4 marks]What do you mean by NDA? Discuss its review process
[6 marks]Which events should be promptly informed by investigator to the ethics committee during clinical study.
[4 marks]Write a short note on regulatory setup in Europe
[4 marks]Explain the importance of dosage form design in pre-clinical and clinical stages.
[6 marks]Describe essential elements of Informed Consent Form (ICF)
[4 marks]Explain the IEC review process of a clinical research proposal Q. 6 (a) Classify randomization process and explain in detail any two methods with advantages and disadvantages.
[6 marks]Write differences between ICH-GCP and ICMR guidelines for conducting clinical research
[4 marks]Differentiate between Cohort study and case control sampling methods
[4 marks]Describe procedure of communicating ADR reports & periodic safety update reports (PSUR)
[6 marks]Write significance of marketing surveillance
[4 marks]Discuss various methods of post marketing surveillance study.
[4 marks]