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Language: English
Published by John Wiley and Sons Ltd, 2010
ISBN 10: 0470118121 ISBN 13: 9780470118122
Seller: Kennys Bookshop and Art Galleries Ltd., Galway, GY, Ireland
First Edition
Condition: New. Because pharmaceutical scientists lack information about biopharmaceutical product manufacture and commercialization, this book comprehensively covers fundamentals and essential pathways for each production phase; as well as the purpose, function, and relation to other stages in the product development process. Editor(s): Jameel, Feroz; Hershenson, Susan. Num Pages: 976 pages, Illustrations. BIC Classification: TCB; TDCW. Category: (P) Professional & Vocational. Dimension: 242 x 159 x 54. Weight in Grams: 1510. . 2010. 1st Edition. Hardcover. . . . .
Gebunden. Condition: New. Because pharmaceutical scientists lack information about biopharmaceutical product manufacture and commercialization, this book comprehensively covers fundamentals and essential pathways for each production phase as well as the purpose, function, and relat.
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Taschenbuch. Condition: Neu. Quality by Design for Biopharmaceutical Drug Product Development | Feroz Jameel (u. a.) | Taschenbuch | AAPS Advances in the Pharmaceutical Sciences Series | xx | Englisch | 2016 | Humana | EAN 9781493951529 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
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Seller: Revaluation Books, Exeter, United Kingdom
Hardcover. Condition: Brand New. 1st edition. 984 pages. 10.00x6.50x2.00 inches. In Stock.
Language: English
Published by JOHN WILEY (ORIGINAL), 2010
ISBN 10: 0470118121 ISBN 13: 9780470118122
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Condition: New. Brand New! Fast Delivery This is an International Edition and ship within 24-48 hours. Deliver by FedEx and Dhl, & Aramex, UPS, & USPS and we do accept APO and PO BOX Addresses. Order can be delivered worldwide within 6-10 days and we do have flat rate for up to 2LB. Extra shipping charges will be requested if the Book weight is more than 5 LB. This Item May be shipped from India, United states & United Kingdom. Depending on your location and availability.
Taschenbuch. Condition: 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.
Buch. Condition: 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.