Analytical Method Development and Validation
| By: | Michael E. Swartz |
| Publisher: | Taylor & Francis |
| Print ISBN: | 9781138402560 |
| eText ISBN: | 9781351991544 |
| Edition: | 1 |
| Copyright: | 1997 |
| Format: | Reflowable |
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Table of Contents
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.