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Analytical Method Development And Validation
by Michael Swartz , Swartz Swartz , Michael Swartz
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Book Summary of Analytical Method Development and Validation
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. isbn
9780824701154
Pages : 96
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