Developing Solid Oral Dosage Forms 2E

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