Description
Book SynopsisThe Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid 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 first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP 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.
Trade ReviewThis six-volume comprehensive handbook is a widely known reference in the field, and the third edition provides an up-to-date overview of the area of pharmaceutical manufacturing formulations. The current edition has greatly improved the previous edition, presenting all aspects related to state-of-the-art pharmaceutical manufacturing formulations.
-Marc A Ilies, PhD, Temple University School of Pharmacy
Table of ContentsPart I Regulatory and Manufacturing Considerations
Chapter 1: Bioequivalence Testing: Rationale and Principle
Chapter 2: Guidance for Industry
Chapter 3: Product-Specific Guidance from FDA on the Development of Compressed Dosage Forms
Chapter 4: Guidance on Formulating Compressed Solids
Part II Manufacturing Formulations
Part III Tablet Coating Formulations
Part IV Composition of Proprietary Products Approved in the United States
