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Analytical Method Development and Validation at Meripustak

Analytical Method Development and Validation

Books from same Author: Michael E Swartz Ira S Krull

Books from same Publisher: Routledge

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    • General Information  
    Author(s)Michael E Swartz Ira S Krull
    PublisherRoutledge
    ISBN9781032501574
    Pages96
    BindingPaperBack
    Publish YearMay 1997

    Description

    Routledge Analytical Method Development and Validation by Michael E Swartz Ira S Krull

    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.