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Ricerca Preclinical Primer - UC Davis Health

Essential IND Strategies: Fundamental Considerations on the Road to Success Darren Warren Drug Discovery & Development Target Identification HTS (High Throughput Screening) Actives to Hits Hit to Lead Lead Optimization (SAR) Preclinical Candidate IND Enabling & Registration Support Studies Clinical Candidate NDA Phase I - III Market Introduction Phase IV API Synthesis, Analytical & Scale-up Focus of Today s Discussion Early Clinical Goals & Regulatory Strategy 1)Define drug development goals: Identify target patient population, rationale for clinical need, & initial region for clinical development.

Item Phase I Range-Finding GLP Toxicology API Needed 50 - 200 grams 0.20 - 2.0 kilograms 2 - 10 kilograms Process Status Discovery route Upgraded to scaleable and

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