Analytical method development and validation
Michael E Swartz
Analytical method development and validation - Boca Raton CRC 2023 - 92p. PB 21.5x14cm.
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.
9781032501574
Analytical chemistry
543 / SWAA
Analytical method development and validation - Boca Raton CRC 2023 - 92p. PB 21.5x14cm.
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.
9781032501574
Analytical chemistry
543 / SWAA
