hershenson susan (14 Ergebnisse)

Zustand: Good. Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions.

Zustand: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Zustand: New. pp. 984.

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Zustand: New. In.

Zustand: New. In.

Gebunden. Zustand: 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.

Taschenbuch. Zustand: 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.

Hardcover. Zustand: Brand New. 1st edition. 984 pages. 10.00x6.50x2.00 inches. In Stock.

Taschenbuch. Zustand: 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. Zustand: 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.

Zustand: 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. . . . . Books ship from the US and Ireland.

Paperback. Zustand: Brand New. reprint edition. 730 pages. 9.25x6.10x1.81 inches. In Stock.

Hardcover. Zustand: Brand New. 9.25x6.25x1.50 inches. In Stock.