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Product Details 基本信息 ISBN-13 书号 9781493951529 Author 作者 Feroz Jameel Amgen Inc. Thousand Oaks CA USA Format 版本 平装-胶订 Pages Number 页数 710页 Publisher 出版社 Springer New York Publication Date 出版日期 2016-10-05 Shipping Weight 商品重量 1104g Language 语种 英语 Book Contents 内容简介 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 dev
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