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Analytical Method Development and Validation

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Hardback
96 Pages
28 September 2017
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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
    ISBN-13
    9781138402560
    Author
    Michael E. Swartz
    Publisher
    CRC Press
    Published
    28 September 2017
    Format
    Hardback
    Pages
    96

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    RRP: $441.00
    $435.00
    Ships in 2-5 business days

    Delivery estimate

    Hurry up! Current stock:

    Analytical Method Development and Validation

    RRP: $441.00
    $435.00

    Description

    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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