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Unit 1 - Part 2 Drug Development Process - Part 2.pptx
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
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