Method Validation in Pharmaceutical Anal

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This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements …

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    Om Method Validation in Pharmaceutical Anal

    This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

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    Detaljer

    Format
    E-Bok
    Filformat
    PDF
    Utgivelsesår
    2014
    Forlag
    Wiley
    Språk
    Engelsk
    ISBN
    9783527672196
    Sider
    480

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