9781493923151 - quality by design for biopharmaceutical drug product development: 18 (11 risultati)
Lingua: Inglese
Editore: Springer, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Lingua: Inglese
Editore: Springer, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Quality by Design for Biopharmaceutical Drug Product Development
Jameel, Feroz (EDT); Hershenson, Susan (EDT); Khan, Mansoor A. (EDT); Martin-moe, Sheryl (EDT)
Lingua: Inglese
Editore: Springer, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Quality by Design for Biopharmaceutical Drug Product Development
Jameel, Feroz (EDT); Hershenson, Susan (EDT); Khan, Mansoor A. (EDT); Martin-moe, Sheryl (EDT)
Lingua: Inglese
Editore: Springer, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: GreatBookPrices, Columbia, MD, U.S.A.GreatBookPrices
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Lingua: Inglese
Editore: Springer, Humana, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH
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Buch. Condizione: 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.
Lingua: Inglese
Editore: Springer, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: Revaluation Books, Exeter, Regno UnitoRevaluation Books
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Quality by Design for Biopharmaceutical Drug Product Development
Jameel, Feroz|Hershenson, Susan|Khan, Mansoor A.|Martin-Moe, Sheryl
Lingua: Inglese
Editore: Springer New York, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Condizione: 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 pharmaceut…ical industries Covers dosage f.
Lingua: Inglese
Editore: Springer, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: Brook Bookstore On Demand, Napoli, NA, ItaliaBrook Bookstore On Demand
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Condizione: new. Questo è un articolo print on demand.
Lingua: Inglese
Editore: Springer, Humana Apr 2015, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermaniaBuchWeltWeit Ludwig Meier e.K.
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Buch. Condizione: 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.
Altre immaginiLingua: Inglese
Editore: Humana, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Buch. Condizione: Neu. Quality by Design for Biopharmaceutical Drug Product Development | Feroz Jameel (u. a.) | Buch | AAPS Advances in the Pharmaceutical Sciences Series | xx | Englisch | 2015 | Humana | EAN 9781493923151 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[do…t]hartmann[at]springer[dot]com | Anbieter: preigu Print on Demand.
Lingua: Inglese
Editore: Springer, Humana Apr 2015, 2015
Serie: AAPS Advances in the Pharmaceutical Sciences, Libro 17 di 38. Libro 17 di 38 - AAPS Advances in the Pharmaceutical Sciences
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Da: buchversandmimpf2000, Emtmannsberg, BAYE, Germaniabuchversandmimpf2000
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Buch. Condizione: 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 boo…k 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.
