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- ÉditeurSpringer-Verlag New York Inc.
- Date d'édition2015
- ISBN 10 1493923153
- ISBN 13 9781493923151
- ReliureRelié
- Nombre de pages710
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Quality by Design for Biopharmaceutical Drug Product Development (AAPS Advances in the Pharmaceutical Sciences Series, 18)
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(2015)
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Description du livre Etat : New. Book is in NEW condition. N° de réf. du vendeur 1493923153-2-1
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Quality by Design for Biopharmaceutical Drug Product Development (AAPS Advances in the Pharmaceutical Sciences Series, 18)
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(2015)
ISBN 10 : 1493923153
ISBN 13 : 9781493923151
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Description du livre Etat : New. New! This book is in the same immaculate condition as when it was published. N° de réf. du vendeur 353-1493923153-new
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Quality by Design for Biopharmaceutical Drug Product Development (AAPS Advances in the Pharmaceutical Sciences Series) [Hardcover ]
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ISBN 10 : 1493923153
ISBN 13 : 9781493923151
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Description du livre Hardcover. Etat : new. N° de réf. du vendeur 9781493923151
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Quality by Design for Biopharmaceutical Drug Product Development
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Springer New York
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ISBN 13 : 9781493923151
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Description du livre Gebunden. Etat : New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Provides an authoritative, detailed and clear explanation of QbD principles and its applications/implications for the development and commercialization of biopharmaceutical drug product for the biotech and pharmaceutical industries Covers dosage f. N° de réf. du vendeur 21268459
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Quality by Design for Biopharmaceutical Drug Product Development
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Springer New York Apr 2015
(2015)
ISBN 10 : 1493923153
ISBN 13 : 9781493923151
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Description du livre Buch. Etat : Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling.Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs. 732 pp. Englisch. N° de réf. du vendeur 9781493923151
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Quality by Design for Biopharmaceutical Drug Product Development
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(2015)
ISBN 10 : 1493923153
ISBN 13 : 9781493923151
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Description du livre Etat : New. N° de réf. du vendeur 22112298-n
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Quality by Design for Biopharmaceutical Drug Product Development
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(2015)
ISBN 10 : 1493923153
ISBN 13 : 9781493923151
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Description du livre Etat : New. N° de réf. du vendeur 22112298-n
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Quality by Design for Biopharmaceutical Drug Product Development
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(2015)
ISBN 10 : 1493923153
ISBN 13 : 9781493923151
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Description du livre Etat : New. PRINT ON DEMAND Book; New; Fast Shipping from the UK. No. book. N° de réf. du vendeur ria9781493923151_lsuk
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Quality by Design for Biopharmaceutical Drug Product Development
Edité par
Springer New York
(2015)
ISBN 10 : 1493923153
ISBN 13 : 9781493923151
Neuf
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Description du livre Buch. Etat : Neu. Druck auf Anfrage Neuware - Printed after ordering - This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling.Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs. N° de réf. du vendeur 9781493923151
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EUR 238,98
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