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Analytical Method Development and Validation

Michael E. Swartz, Ira S. Krull · ISBN 9780824701154
Analytical Method Development and Validation | Zookal Textbooks | Zookal Textbooks
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Publisher Taylor and Francis
Author(s) Michael E. Swartz / Ira S. Krull
Published 16th May 1997
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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.
Translation missing: en.general.search.loading