Preclinical Development Primer 201 builds upon the established knowledge in Preclinical Development Primer 101, utilizing real-world examples and case studies to delve deep into the specific tests and data required to file a successful Investigational New Drug (IND) application. The class focuses first on efficacy, centered around pharmacology studies, including binding and potency assays, and second on safety, including ADME, HERG, DART, PK/PD, mutagenicity, and carcinogenicity testing. This primer examines each preclinical test's goals and outcomes, evaluating data results to determine therapeutic margin, side effects, and optimal drug concentration. Finally, the class describes the workflow, timeline, and standards for validating and qualifying these tests. Don't miss this opportunity to understand preclinical developments. secure your spot today!
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