ABSTRACT

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

part I|180 pages

Regulatory and Manufacturing Guidance

chapter 1|13 pages

Waiver of In Vivo Bioequivalence Study

chapter 2|9 pages

Quality Risk Management

chapter 3|8 pages

Pharmaceutical Quality System

chapter 4|7 pages

Pharmaceutical Development

chapter 5|4 pages

Pharmaceutical Development in CTD

chapter 8|2 pages

Validation of Analytical Procedures

chapter 10|5 pages

Bioequivalence Testing of Topical Drugs

chapter 15|5 pages

Impurities in New Drug Substances

chapter 16|7 pages

Impurities in New Drug Products

part II|154 pages

Manufacturing Formulations

chapter |153 pages

Regulatory and Manufacturing Guidance