发表于2024-11-04
Analytical Regulatory and Validation Compliance 2024 pdf epub mobi 电子书
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This book 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.
Analytical Regulatory and Validation Compliance 2024 pdf epub mobi 电子书