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FDA acceptance criteria for extrapolations

  • 1.  FDA acceptance criteria for extrapolations

    Posted 10-Jul-2018 09:54
    ​​Hi All,
    I got a question about the linear extrapolation (of stability data) - what R-square range (from a regression/extrapolation model) would be acceptable by FDA?
    Thank you,
    Konrad

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    Konrad Kulak
    Frederick MD
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