Taylor & Francis Publishing 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.
Book News Concisely explains specific approaches to developing, optimizing, and validating analytic methods based on high-performance liquid crystallography. Demonstrates how the steps can be integrated into a formal process reflecting the present regulations of the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH). No index. Annotation c. by Book News, Inc., Portland, Or.