Developing Solid Oral Dosage Forms

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