ISBN: 9781482229776
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.
| Edition : | 17 |
| Number of Pages : | 95 |
| Published : | 09/28/2017 |
| isbn : | 9781482229776 |
