Industrial Pharmacy II Unit III Questions

10-Mark Questions:

1.     Explain the historical overview of Regulatory Affairs. Describe the role and responsibilities of the Regulatory Affairs department in the process of drug approval. (10 marks)

2.     Write in detail about Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology.

5-Mark Questions:

3.     What is an Investigational New Drug (IND) Application? Discuss the general considerations that need to be addressed when preparing an IND Application. (5 marks)

4.     Explain about Clinical Research Protocols in pharmaceutical product development. How do these protocols contribute to regulatory approval? (5 marks)

5.     What is the significance of Biostatistics in pharmaceutical product development? How does it help in the regulatory approval process? (5 marks)

6.     Discuss the role of Drug Metabolism and Toxicology in the drug development process. Why is it crucial to consider these factors when seeking regulatory approval? (5 marks)

7.     How does the management of clinical studies impact the regulatory approval of drugs? Explain the key aspects that Regulatory Affairs Professionals need to oversee in clinical studies. (5 marks)

2-Mark Questions:

8.     What are Regulatory Authorities in the context of pharmaceuticals, and why are they important? (2 marks)

9.     Briefly outline the contents of an Investigator's Brochure (IB) and its relevance in drug development. (2 marks)

10.  Why is Data Presentation for FDA Submissions essential during the drug approval process? (2 marks)

11.  Define Clinical Research/Bioequivalence (BE) studies and their significance in the regulatory approval of pharmaceutical products. (2 marks)

12.  Explain the concept of Drug Development Teams and their role in the regulatory affairs process. (2 marks)

13.  In simple terms, what is the primary goal of Non-Clinical Drug Development in the drug approval process? (2 marks)

14.  What is the New Drug Application (NDA), and how does it fit into the regulatory approval process for new drugs? (2 marks)