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  • 1.  number of stability Batches

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jun-2022 08:56
    This message was posted by a user wishing to remain anonymous

    Hello All,
    In IND application how many batches should be reported for the stability studies?
    Thanks


  • 2.  RE: number of stability Batches

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jun-2022 15:41
    This message was posted by a user wishing to remain anonymous

    Check the CMC guidance for phase 1, 2 or 3. Concurrent stability is allowed. For phase 1, one clinical batch should suffice but also you should consider batches on stability that were not for clinical use but made initially as experimental batches to support the new clinical batch.
    Original Message


  • 3.  RE: number of stability Batches

    Posted 11-Jun-2022 18:12
    Hi There
    The stability data (minimum 1 month) can be provided on any number of clinical batches (minimum 1) manufactured. In addition data on technical batches manufactured before clinical batch manufacture should also be provided.

    ------------------------------
    SHARRY ARORA
    Loughrea
    Ireland
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    Original Message


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