Biopharmaceutics to Inform Candidate Drug Selection and Optimisation 7.1 Introduction 7.2 Oral Product Design Considerations During Early Development 7.3 Biopharmaceutics in Drug Discovery 7.4 Biopharmaceutics Assessment 7.5 Output of Biopharmaceutics Assessment 7.6 Influence/Optimise/Design Properties to Inform Formulation Development 7.7 Conclusion References
14 8 Biopharmaceutics Tools for Rational Formulation Design 8.1 Introduction 8.2 Formulation Development to Optimise Drug Bioavailability 8.3 Traditional Formulation Strategies 8.4 Decision Trees to Guide Formulation Development 8.5 Computational Tools to Guide Formulation Strategies 8.6 Decision‐Making for Optimising Enabling Formulations 8.7 Decision Trees for Enabled Formulations 8.8 System‐Based Formulation Strategies 8.9 Biopharmaceutics Risk Assessment Roadmap (BioRAM) 8.10 Conclusions References
15 9 Biopharmaceutic Classification System 9.1 Description and History of the BCS 9.2 BCS‐Based Criteria for Solubility, Dissolution and Permeability 9.3 BCS‐Based Biowaivers 9.4 Regulatory Development of BCS‐Based Biowaivers 9.5 International Harmonisation of BCS‐Based Biowaiver Criteria – ICH M9 9.6 BCS as a Development Tool 9.7 Beyond the BCS 9.8 Conclusions References
16 10 Regulatory Biopharmaceutics 10.1 Introduction 10.2 Clinical Bioequivalence Studies 10.3 Design of Clinical Bioequivalence (BE) Studies 10.4 Implication of Bioequivalence Metrics 10.5 Bioequivalence Regulatory Guidelines 10.6 Biowaivers 10.7 Biopharmaceutics in Quality by Design 10.8 Control of Drug Product and Clinically Relevant Specifications 10.9 Establishing Clinically Relevant Dissolution Methods and Specifications 10.10 Application of In Silico Physiologically Based Biopharmaceutics Modelling (PBBM) to Develop Clinically Relevant Specifications 10.11 Additional Considerations for Establishing Dissolution Methods and Specifications 10.12 Common Technical Document (CTD) 10.13 Other Routes of Administration and Locally Acting Drug Products 10.14 Conclusion References
17 11 Impact of Anatomy and Physiology 11.1 Introduction 11.2 Influence of GI Conditions on Pharmacokinetic Studies 11.3 The Stomach 11.4 Small Intestine 11.5 The Colon/Large Intestine 11.6 Conclusions References
18 12 Integrating Biopharmaceutics to Predict Oral Absorption Using PBPK Modelling 12.1 Introduction 12.2 Mechanistic Models 12.3 Solubility Inputs 12.4 Dissolution Inputs 12.5 Permeability Inputs 12.6 Incorporation of Modelling and Simulation into Drug Development 12.7 Conclusions References
19 13 Special Populations 13.1 Introduction 13.2 Sex Differences in the Gastrointestinal Tract and Its Effect on Oral Drug Performance 13.3 Ethnic Differences in the Gastrointestinal Tract 13.4 Impact of Diet on Gastrointestinal Physiology 13.5 Pregnancy and Its Effect