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  • 1.  missing samples in assays - how FDA regulates it?

    Posted 27-Oct-2017 11:18
    ​Dear All,
    Has anybody know how FDA suggests to handle missing samples/data in assay analysis?
    Are the reruns of the missed samples accepted?
    Any help is greatly appreciated.
    Thank you,
    Konrad

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    Konrad Kulak
    Biostat Solutions, Inc.
    Frederick MD
    United States
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  • 2.  RE: missing samples in assays - how FDA regulates it?

    Posted 28-Oct-2017 09:02
    Hi Konrad,

    I am assuming you are asking missing clinical samples. For clinical samples FDA has following guidance on handling data for population analysis. Section VII.


    https://www.fda.gov/downloads/drugs/guidances/UCM072137.pdf
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    Yogesh 





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    Yogesh Patel RAC, MS
    Bridgewater NJ
    United States
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    Original Message


  • 3.  RE: missing samples in assays - how FDA regulates it?

    Posted 30-Oct-2017 07:39
    ​Thank you very much Yogesh,
    Konrad

    ------------------------------
    Konrad Kulak
    Biostat Solutions, Inc.
    Frederick MD
    United States
    ------------------------------

    Original Message


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