9781493923151 - quality by design for biopharmaceutical drug product development: 18 (aaps advances in the pharmaceutical sciences series, 18) (8 resultados)
Idioma: Inglés
Editorial: Springer, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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Librería: Bay State Book Company, North Smithfield, RI, Estados Unidos de AmericaBay State Book Company
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EUR 142,24
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Idioma: Inglés
Editorial: Springer, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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Librería: Ria Christie Collections, Uxbridge, Reino UnidoRia Christie Collections
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Condición: New. In.
Idioma: Inglés
Editorial: Springer, Humana, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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Librería: AHA-BUCH GmbH, Einbeck, AlemaniaAHA-BUCH GmbH
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Buch. Condición: 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.
Idioma: Inglés
Editorial: Springer, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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Librería: Revaluation Books, Exeter, Reino UnidoRevaluation Books
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Hardcover. Condición: Brand New. 9.25x6.25x1.50 inches. In Stock.
Quality by Design for Biopharmaceutical Drug Product Development
Jameel, Feroz|Hershenson, Susan|Khan, Mansoor A.|Martin-Moe, Sheryl
Idioma: Inglés
Editorial: Springer New York, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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Librería: moluna, Greven, Alemaniamoluna
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Condición: 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 pharmaceuti…cal industries Covers dosage f.
Idioma: Inglés
Editorial: Springer, Humana Apr 2015, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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Librería: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, AlemaniaBuchWeltWeit Ludwig Meier e.K.
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EUR 246,09
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Buch. Condición: 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.
Idioma: Inglés
Editorial: Springer, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
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- Impresión bajo demanda
Librería: Brook Bookstore On Demand, Napoli, NA, ItaliaBrook Bookstore On Demand
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EUR 190,30
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Condición: new. Questo è un articolo print on demand.
Idioma: Inglés
Editorial: Springer, Humana Apr 2015, 2015
Serie: Libro 17 de 38 - AAPS Advances in the Pharmaceutical Sciences
- Tapa dura
- Impresión bajo demanda
Librería: buchversandmimpf2000, Emtmannsberg, BAYE, Alemaniabuchversandmimpf2000
Contactar con el vendedorVendedor de 5 estrellasCondición: Nuevo
EUR 246,09
Envío por EUR 60,00Se envía de Alemania a Estados Unidos de AmericaCantidad disponible: 1 disponibles
Buch. Condición: Neu. This item is printed on demand - Print on Demand Titel. 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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 732 pp. Englisch.
