The document summarizes the clinical research regulations and drug development process. It discusses that developing new drugs is an expensive, time-consuming, and cumbersome process that involves targeting diseases, conducting animal studies to test safety and side effects, and submitting investigational new drug applications to the FDA. The development process also includes multiple phases of clinical trials on humans to further test safety and efficacy.

1. Clinical Research Regulations
PG SEM I (MRA 103T)
Unit 1: Drug Development Process
Dimple Marathe
Assistant Professor
Sanjivani College of Pharmaceutical Education & Research
Kopargaon

2. New Drug Development
• The process is:
• Expensive
• Time consuming
• Cumbersome

3. Pharma - The R&D Pipeline

4. Disease Targeting

5. Phases of Clinical Trials

6. Safety Testing - Animal Studies
• Pharmacokinetics and Pharmacodynamics
• Side effects and Toxicities
• Correct early absorption and Toxicity problems
• Submit Investigational New Drug (IND) to FDA

7. References
• Rosenbaum.D,Dresser.M,chapter 1 : Phases Of Clinical Research,
Clinical Research coordinator Handbook GCP:Tools and
Techniques,2nd Edition 2002

8. Thank You