Analytical Method Development and Validation
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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.
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Product details
Author: Michael E. Swartz
Format: Hardback|1138402567pages
Dimensions:138 x 216 x 12mm | 227g
Publication Date: 43007
Publisher: Taylor & Francis Ltd
Language: English
ISBN 10: 1138402567
ISBN 13: 9781138402560