Michael E. Swartz 
Analytical Method Development and Validation [PDF ebook] 

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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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格式 PDF ● 网页 96 ● ISBN 9781482229776 ● 编辑 Michael E. Swartz ● 出版者 CRC Press ● 发布时间 2018 ● 下载 3 时 ● 货币 EUR ● ID 6738219 ● 复制保护 Adobe DRM
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