I: Theories and Techniques in the Characterization of Drug Substances and Excipients 1. Solubility of Pharmaceutical Solids 2. Crystalline and Amorphous Solids 3. Solid State Characterization and Techniques 4. API Solid-Form Screening and Selection 5. Drug Stability and Degradation Studies 6. Excipient Compatibility and Functionality 7. Polymer Properties and Characterization 8.

Interfacial Phenomenon 9. The Fundamentals of Diffusion and Dissolution 10. Particle, Powder, and Compact Characterization II: Biopharmaceutical and Pharmacokinetic Evaluations of Drug Molecules and Dosage Forms 11. Oral Drug Absorption: Pathways, Physicochemical and Biological Factors, and Methods of Study 12. Evaluation of Drug Absorption from Oral Dosage Forms 13. Dissolution Testing of Solid Oral Products 14. Bioavailability and Bioequivalence 15. Dissolution Evaluation of Enabling Formulations Based on Supersaturation 16.

In Vitro-In Vivo Correlations: Fundamentals, Development Considerations and Applications III: Design, Development and Scale-up of Formulation and Manufacturing Process 17. Patient-centric Drug Product Design: Rational and Practical Considerations 18. Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway 19. Oral Formulations for Preclinical Studies: Principle, Design, and Development 20. Product and Process Development of Solid Oral Dosage Forms 21. Rational Development of Amorphous Solid Dispersions 22. Rational Design of Oral Modified-Release Drug Delivery Systems 23. Basics and Applications of DOE in Product Development, Scale-up and Optimization 24.

Modeling of Manufacturing Processes of Solid Drug Products 25. Analytical Method Development of Solid Dosage Forms 26. Statistical Design and Analysis of Long Term Stability Studies for Drug Products 27. Packaging Selection for Solid Dosage Forms 28. Clinical Supplies Manufacture: Strategy, GMP Considerations, and Cleaning Validation 29. Specification Setting and Manufacturing Process Control for Solid Oral Drug Products 30. Process Development and Scale-Up: Providing Reliable Powder Flow and Product Uniformity 31. Capsule Dosage Forms: Formulation and Manufacturing Considerations 32.

Process Development and Scale-Up: High Shear Wet Granulation Process 33. Process Development and Scale-Up: Fluid-bed Granulation 34. Process Development and Scale-Up: Spray-Drying Amorphous Solid Dispersions for Insoluble Drugs 35. Process Development and Scale-Up: Twin Screw Hot Melt Extrusion and Continuous Granulation 36. Development, Scale-Up, and Optimization of Process Parameters: Roller Compaction Theory and Practice 37. Development, Scale-Up, and Optimization of Process Parameters: Tablet Compression 38. Development and Scale-Up of Process Parameters: Pan Coating 39. Development, Scale-Up, and Optimization of Process Parameters: Wurster Coating 40.

Commercial Manufacturing and Product Quality 41. New Technologies for Modernizing Pharmaceutical Production: Continuous Manufacturing and 3D printing 42. Machine Learning and Artificial Intelligence in Product & Process Development and Manufacturing Part IV: Regulatory Aspects of Product Development 43. Drug Product Approval in the US and ICH 44. Modern Pharmaceutical Regulations: Quality Assessment for Drug Substance 45. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products.