1. TOPRA Annual Veterinary Symposium Introduction to the Case Study A presentation by Lesley Reeve, Module leader

2.  Timing  Run over 2 days  Start 16:20 today (up to 2.5 hours), continued tomorrow (1 hour)  Structure  Part A - Approaches to support clinical development stages (FIM, Phase II/III and marketing) [~45 min]  Part B – New impurities during scale up [~30 min]  Part C – Major human metabolite [~30 min] Case Study Introduction

3. Study design:  Endpoint (pharmacology, safety pharmacology, kinetics, general toxicity, genetic toxicity, reproductive / developmental toxicity, carcinogenicity, other toxicities)  Species (rodent & non-rodent)  Duration of the studies Case Study - Considerations

4.  The Lectures!  ICH M3 Guideline on “Nonclinical Safety studies for the conduct of human clinical trials for Pharmaceuticals”  ICH ‘S’ (safety) guidelines  ICHQ3A & Q3B & ICH M7 (guidance on impurities)  FDA “Guidance for Industry, Safety Testing of Drug Metabolites”  ICH M3 Q&A document. Case Study – Useful References

5. QUESTIONS?