by Michael E. Swartz (Editor), Ira S. Krull (Editor)
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.
Number of Pages: 96
Dimensions: 0.19 x 8.18 x 5.96 IN
Publication Date: January 01, 2001