Handbook of Pharmaceutical Manufacturing Formulations: Sterile Drugs - Couverture rigide

Niazi, Sarfaraz K.

Couverture rigide

ISBN 10 : 0849317517 ISBN 13 : 9780849317514

Editeur : CRC Press Inc, 2004

A propos du livre

Présentation de l'éditeur :

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.

À propos de cette édition

• Éditeur: CRC Press Inc
• Date d'édition: 2004
• ISBN 10: 0849317517
• ISBN 13: 9780849317514
• Reliure: Relié
• Nombre de pages: 354