Handbook of Pharmaceutical Manufacturing Formulations, Third Edition-Volume Four, Semisolid Products

Part I Regulatory and Manufacturing Guidance
Chapter 1. Waiver of In Vivo Bioequivalence Study
Chapter 2. Quality Risk Management
Chapter 3. Pharmaceutical Quality System
Chapter 4. Pharmaceutical Development
Chapter 5. Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment
Chapter 6. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Chapter 7. Validation of Analytical Procedures
Chapter 8. Bioequivalence Testing of Topical Drugs
Chapter 9. Active Pharmaceutical Ingredients: GMP Compliance and Inspection
Chapter 10. Test Procedures and Acceptance Criteria for New Chemical Drug Substances and Drug Products
Chapter 11. Topical Testing of Transdermal Drug Products
Chapter 12. Impurities Profiling: Drug Substance
Chapter 13. Impurities in New Drug Products
Chapter 14. Formulation Factors in Semisolid Dosage Forms
Chapter 15. Pediatric Research Equity Act (PREA) Compliance
Chapter 16. Global Regulatory Guidance on Bioequivalence Testing
Chapter 17. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations
Chapter 18. FDA 483 Observations
Chapter 19. WHO Good Manufacturing Guidelines
Appendices
Part II Manufacturing Formulations
Semisolid Formulations
Part III Commercial Pharmaceutical Formulations
Commercial Pharmaceutical Formulations