Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products (Volume 6 of 6) - Hardcover
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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- PublisherCRC Press
- Publication date2004
- ISBN 10 0849317517
- ISBN 13 9780849317514
- BindingHardcover
- Edition number1
- Number of pages354
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Handbook of Pharmaceutical Manufacturing Formulations - 6 Volume Set: Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products (Volume 6 of 6)
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Handbook of Pharmaceutical Manufacturing Formulations: Sterile Drugs: Sterile Products (Volume 6 of 6)
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CRC Press Inc
(2004)
ISBN 10: 0849317517
ISBN 13: 9780849317514
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Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products (Volume 6 of 6)
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