| 书目名称 | Handbook of Stability Testing in Pharmaceutical Development | | 副标题 | Regulations, Methodo | | 编辑 | Kim Huynh-Ba | | 视频video | http://file.papertrans.cn/423/422229/422229.mp4 | | 概述 | This practical handbook is needed in this area to serve pharmaceutical scientists who handle responsibilities in a variety of functions relating to the drug stability, including R&D, formulation, anal | | 图书封面 |  | | 描述 | .A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT...Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs....Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. ...Topics covered include:....Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and gl | | 出版日期 | Book 2009 | | 关键词 | Development; Huynh-Ba; Huynhba; Methodologies; Pharmaceutical; Regulations; Stability; Testing; drug | | 版次 | 1 | | doi | https://doi.org/10.1007/978-0-387-85627-8 | | isbn_softcover | 978-1-4419-2756-9 | | isbn_ebook | 978-0-387-85627-8 | | copyright | Springer-Verlag New York 2009 |
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