TY  - BOOK
AU  - Michael E Swartz
AU  - Krull, Ira S
TI  - Analytical method development and validation
SN  - 9781032501574
U1  - 543 23
PY  - 2023///
CY  - Boca Raton
PB  - CRC
KW  - Chemistry
KW  - Analytical chemistry
N2  - 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
ER  -