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  • 1.  WHO Posts M10

    Community Leadership
    Posted 08-21-2025 10:58

    The WHO has recently posted a version of ICH M10.

    https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/regulatory-standards/annex-6_guideline-on-bioanalytical-method-validation-and-study-sample-analysis.pdf?sfvrsn=4fc96250_3

    Any thoughts on whether this extends the applicability of M10 beyond ICH member countries to those that are members of WHO?

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    Eric Woolf, Ph.D., FAAPS
    Souderton, PA

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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