Oral Formulation Roadmap from Early Drug Discovery to Development

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. •    Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry •    Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research •    Features case studies to illustrate practical challenges and solutions in formulation selection •    Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing

List of Contributors vii Preface ix 1 Introduction 1 Elizabeth Kwong 2 Lead Identification/Optimization 9 Mei Wong and Mark McAllister 3 Oral Drug Formulation Development in Pharmaceutical Lead Selection Stage 39 Shayne Cox Gad 4 Bridging End of Discovery to Regulatory Filing: Formulations for IND-and Registration-Enabling Nonclinical Studies 89 Evan A. Thackaberry 5 Planning the First Clinical Trials with Clinical Manufacturing Organization (CMO) 115 Elizabeth Kwong and Caroline McGregor 6 Formulation Strategies for High Dose Toxicology Studies: Case Studies 139 Dennis H. Leung, Pierre Daublain, Mengwei Hu and Kung]I Feng 7 Formulation, Analytical, and Regulatory Strategies for First-in-Human Clinical Trials 165 Lorenzo Capretto, Gerard Byrne, Sarah Trenfield, Lee Dowden and Steven Booth Index 243