Specification of Drug Substances and Products:Development and Validation of Analytical Methods

药物和产品规范:分析方法的开发和验证 第2版

药理学

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1805.00
发货周期:预计4-6周发货
作      者
出  版 社
出版时间
2019年08月01日
装      帧
平装
ISBN
9780081028247
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页      码
712
语      种
英文
版      次
2nd ed.
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图书简介
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered-or not substantially covered-in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book’s authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
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