1 Developability Assessment and Risk Management During Drug Discovery -- 2 Discovery Formulations – Approaches and Practices in Early Preclinical Development -- 3 Enabling Discovery Through Leveraging and Miniaturizing Pharmaceutical Principles and Processes -- 4 Diagnosing Biopharmaceutical Limitations -- 5 The Importance of Molecular Design Principles in Delivering High Quality Pharmaceutical Candidates -- 6 Predictive Approaches to Establishing, Understanding, and Communicating Risk with Emphasis on Early Development -- 7 Strategies and Methods for Drug Candidate Phase Optimization in Discovery Space -- 8 Efficient Laboratory Methods to Assess Risk and Design Formulations -- 9 Advanced X-ray Analytical Methods to Understand Structure, Properties and Risk -- 10 Performance and Characterization of Amorphous Solid Dispersions: An Overview -- 11 Hot-Melt Extrusion: The Process-Product-Performance Interplay -- 12 Practical Considerations for Spray Dried Formulation and Process Development -- 13 Nanosizing: “End-to-End” Formulation Strategy for Poorly-Water- Soluble Molecules -- 14 Leveraging Solid State Form and Physiochemical Properties for Early Clinical Formulation Efforts: Opportunities and Challenges during Telcagepant Liquid Capsule Development.

This authoritative volume provides a contemporary view on the latest research in molecules with optimal drug-like properties. It is a valuable source to access current best practices as well as new research techniques and strategies. Written by leading scientists in their fields, the text consists of fourteen chapters with an underlying theme of early collaborative opportunities between pharmaceutical and discovery sciences. The book explores the practical realities of performing physical pharmaceutical and biopharmaceutical research in the context of drug discovery with short timelines and low compound availability. Chapters cover strategies and tactics to enable discovery as well as predictive approaches to establish, understand and communicate risks in early development. It also examines the detection, characterization and assessment of risks on the solid state properties of advanced discovery and early development candidates, highlighting the link between solid state properties and critical development parameters such as solubility and stability. Final chapters center on techniques to improve molecular solubilization and prevent precipitation, with particularly emphasis on linking physiochemical properties of molecules to formulation selection in preclinical and clinical settings.