Analytical Method Development and Validation

CRC Press

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. This text also presents an overview of Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) regulatory guidelines. > 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. > Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and rel