http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.
edited by Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lawrence Yu, Rao V. Mantri.
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.
Includes bibliographical references and index.