Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products (Volume 6 of 6)

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Taylor & Francis, Apr 27, 2004 - Medical - 354 pages
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The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms.

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About the author (2004)

Pakistani doctor Sarfaraz K. Niazi has been teaching in the field of pharmaceutical sciences for over 34 years. He has published over 100 research articles and over a dozen major books including textbooks and a book on patent filing. He is the recipient of several research recognition awards. He is a licensed practitioner of patent law in the United States and serves the global pharmaceutical and biotechnology industry in the transition of research ideas into useful technology. Niazi holds several major US and worldwide patents for his inventions and writes in the fields of philosophy, sociology, rhetoric and poetry. He is the author of the first book on clinical pharmacokinetics and the largest work on pharmaceutical manufacturing formulations and also on the manufacturing of therapeutic proteins. He holds several fellowship of learned societies and is a reviewer for scientific journals. He writes poetry in several languages and as a hobby translates ancient Urdu and Persian poetry into English.

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