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  • 1.  Bioequivalence Study for Tablet Crushing

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jun-2020 12:10
    This message was posted by a user wishing to remain anonymous

    Dear Forum,

    For an immediate-release tablet, is it necessary to conduct a bioequivalence study between the whole and crushed tablet?

    Thank you for your help!


  • 2.  RE: Bioequivalence Study for Tablet Crushing

    Posted 25-Jun-2020 06:51
    If the purpose for crushing the immediate-release tablet is to administer it through something like a G-tube in a liquid or mix into a food like applesauce, it should not be necessary to do a bioequivalence study, but considerations should be given to whether stability in the liquid/food needs to tested.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Bioequivalence Study for Tablet Crushing

    Posted 25-Jun-2020 07:34
    Is Product specific guidance available?
    If yes, follow as per guidance.
    If not, you can submit controlled correspondence with FDA.

    ------------------------------
    CHIRAGKUMAR PATEL
    REGULATORY AFFAIRS
    Boca Raton FL
    United States
    ------------------------------

    Original Message


  • 4.  RE: Bioequivalence Study for Tablet Crushing

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jun-2020 08:59
    This message was posted by a user wishing to remain anonymous

    No, if it meets the normal dissolution criteria for an immediate release dosage form.
    Original Message


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