Contents

7.1 Introduction 205

7.2 Challenge and Vision 206

7.3 In Vitro Assays 207

7.3.1 Caco-2 Assay 208

7.3.2 Enzyme Inhibition Assay 208

7.3.3 In Vitro Metabolic Stability Assay 209

7.4 In Vivo Assays 210

7.4.1 Discovery PK Screening Assays: Sample Reduction 210

7.4.2 Discovery PK Studies: Sample Preparation 212

7.4.3 Discovery PK Studies: Rapid Method Development 212

7.4.4 Discovery PK Studies: Rules for Acceptance Criteria for Discovery Assays 213

7.4.5 Discovery PK Studies: Metabolite Profiling 214

7.4.6 Discovery PK Studies: Matrix Effects 220

7.4.7 Discovery PK Studies: Faster Assays with Faster Chromatography 221

7.4.8 Metabolite Identification 223

7.5 Conclusions 228

References 228

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