Previous edition: 2009.

Part I: Theories and Techniques in the Characterization of Drug Substances and Excipients -- 1. Solubility of Pharmaceutical Solids -- 2. Crystalline and Amorphous Solids -- 3. Analytical Techniques in Solid State Characterization -- 4. Salt and Solid Form Screening and Selection -- 5. Drug Stability and Degradation Studies -- 6. Excipient Functionality and Compatibility -- 7. Polymer Properties and Characterization -- 8. Surface phenomenon and pharmaceutical applications -- 9. The Fundamentals of Diffusion and Dissolution -- 10. Particle, Powder, and Compact Characterization -- Part II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms -- 11. Oral Absorption Basics: Pathways, Physicochemical and Biological Factors, and Methods of Stud -- 12. Oral Absorption Evaluation -- 13. Dissolution Testing of Solid Products -- 14. Bioavailability and Bioequivalence -- 15. Predictive Biopharmaceutics and Pharmacokinetics: Modeling and Simulation -- 16. In Vitro-In Vivo Correlations: Fundamentals, Development Considerations and Applications -- Part III: Design, Development and Scale-up of Formulation and Manufacturing Process -- 17. Development of formulations for drug discovery support -- 18. Enabling formulation technology for developing solid dosage form of insoluble drugs -- 19. Rational Design of Oral Modified-Release Drug Delivery Systems -- 20. Product and Process Development of Solid Oral Dosage Forms -- 21. Analytical Development and Validation for Dosage Forms -- 22. Statistical Design and Analysis of Long Term Stability Studies for Drug Products -- 23. Packaging Selection for Solid Dosage Form -- 24. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation -- 25. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products -- 26. Process Development and Scale-Up: Powder Handling and Segregation Concerns -- 27. The Formulation and Manufacturing of Capsules -- 28 Design, Development, and Scale-Up of the High-Shear Wet Granulation Process -- 29. Process Development, Optimization, and Scale-Up: Fluid-Bed Granulation -- 30. Formulation, Process Development, and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs -- 31. Process Development and Scale-Up: Twin-Screw Extrusion -- 32. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice -- 33. Development, Optimization, and Scale-Up of Process Parameters: Tablet Compression -- 34. Development, Optimization, and Scale-Up of Process Parameters: Pan Coating 35. Development, Optimization, and Scale-Up of Process Parameters: Wurster Coating -- 36. Commercial Manufacturing and Product Quality -- 37. Emerging Technology for Modernizing Pharmaceutical Production: Continuous Manufacturing -- Part IV: Regulatory Aspects of Product Development -- 38. Drug Product Approval in the United States and International Harmonization -- 39. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substances -- 40. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products.