Analytical Method Development and Validation

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 revalidation.

Undergraduate

Michael E. Swartz, Ira S. Krull

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