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.
發表於2025-02-05
Analytical Regulatory and Validation Compliance 2025 pdf epub mobi 電子書 下載
圖書標籤:
Analytical Regulatory and Validation Compliance 2025 pdf epub mobi 電子書 下載