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EMA - Implementation strategy of ICH Guideline M12 on drug interaction studies

  • 1.  EMA - Implementation strategy of ICH Guideline M12 on drug interaction studies

    Posted 02-13-2025 08:08

    EMA identified a number items in its guidelines that were not covered by the ICH M12 guideline and have issued this very brief document that states those items in prior guidelines that remain in effect. 

    #EMA  #ICH #M12 #DDI

    https://www.ema.europa.eu/en/documents/scientific-guideline/implementation-strategy-ich-guideline-m12-drug-interaction-studies_en.pdf



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    Mark Arnold Ph.D., FAAPS
    Westampton, NJ
    [email protected]
    Bioanalytical Solution Integration
    LinkedIn: https://www.linkedin.com/in/markearnoldphd/
    Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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