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Handbook of Pharmaceutical Manufacturing Formulations Six Volume Set

Pharmaceutical formulations remain as much an art today as they have evolved into complex science. With exponential growth of generic formulations, the need for ready formulations has increased. Essentially an authoritative practical guide in the art and science of formulating drugs, the six-volume handbook contains the Bill of Materials and Manufacturing Directions for over 2000 drug formulations, including a number of biotechnology and patented drugs. The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications and other sources of generic and proprietary formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations. Each volume of the series is divided into two parts: the section on regulatory and manufacturing guidelines and the section on formulations. The series provides chapters on issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing, bioequivalence testing, packaging commodity development, changes to aNDAs, SUPAC for equipment and a large number of other relevant and current topics of interest to the pharmaceutical industry. Each category of drug formulations, as classified in a separate volume, is analyzed for the common difficulties in formulating drugs. This book is the first of its kind published in the pharmaceutical literature and is a must collection for all pharmaceutical manufacturers, educational institutions and regulatory authorities. Companies with large formulation teams will find this book an excellent platform for benchmarking their own products and the generic companies will find this book an excellent source of information prior to embarking on formulating drugs coming off patent; this book will mean getting on the filing of the aNDAs in the shortest possible time. This book should also serve as an excellent teaching tool, not only for those working in the manufacturing environment but also in academia.

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