Developability Assessment Short Course Overview Introduction and Overview • Purpose and Goals • Drug Discovery and Development Logic Plan • Where Developability Assessment Fits Into the Logic Plan • Overview of Developability Assessment Scientific Disciplines • Review of Drug Discovery In Vitro and In Vivo Pharmacology • In Vitro Pharmacology > Expansion of Drug Discovery Results > Determination of IC50 and IC90 Values > Example In Vitro Dose Response Curves • In Vivo Pharmacology > Definition and Characterization of Animal Models > Determination of ED50 and ED10 Values and Therapeutic Ratio > Example In Vivo Dose Response Curves Early Formulation Evaluations • Analytical Chemistry Method Development and Characterization • Early Formulation Definition and Assessments • Stability and Solubility Requirements • Example Stability and Solubility Profiles In Vitro Drug Metabolism and Delivery • In Vitro Metabolism > GYP450 Isozymes, Microsomes, and/or Hepatocytes > Phase II Metabolism > Species Comparisons > Example Metabolism Profiles • In Vitro Delivery > GI Tract and Example Absorption Profiles > Blood Brain Barrier > Skin and Other Member Types Preliminary Animal Pharmacokinetics • Bioanalytical Chemistry Method Development and Characterization • Preliminary Protein Binding • Pharmacokinetic Experiments and Example Profiles • Search for Metabolites in Plasma, Urine, Bile Early Toxicology Assessments • In Vitro Toxicology • Acute or Single-Dose Toxicology • Safety Pharmacology • Genotoxicity Developability Assessment Logic Plan Generation Examples Workshop to Design and Discuss Participant Prepared Developability Assessment Logic Plans