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Essential IND Strategies: Fundamental Considerations on ...

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. Goal should not simply be to file an IND, rather develop a drug therapy 2)Initial clinical trials designed to characterize: Human DMPK, safety, pharmacologic activity & proof of concept 3)Understand regulatory guidelines and precedented approaches for similar drugs (same chemical class & indication or relevant) 4)Chemical development

drug formulations, with well characterized impurity profiles. 5) ... Does not address potential genotoxic impurities in API Genetic Toxicology . Requirements ICH Core Battery: ... Small molecule – commonly stand alone studies Biological – …

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