Regulatory Open Forum

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  • 1.  Comparability studies

    Posted 29-Apr-2016 08:49

    Hi,

    I will appreciate if someone could tell me how many lots are required for a comparability study for stability?  Does the agency require one lot or 3 lots of the drug substance and drug product?

    Thanks,

    Betzy

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    Betzy Maldonado
    East Greenbush NY
    United States
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