Main description:

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author's own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Features:

Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions

Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing

Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements

Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Contents:

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