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  • 1.  INDs for Different Formulations

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2019 09:11
    This message was posted by a user wishing to remain anonymous

    I just read the other post about having separate INDs for the IR and XR formulations, which made me question the IND I am currently working on.  We have 1 IND and it contains an IR and DR formulation.  Is this not correct?  It's in eCTD format and each formulation has it's own 3.2.P section. It's been this way for over a year and the Division did not notify me that a separate IND had to be filed.  Should I leave as is or should I contact the Division to discuss?

    Thank you for your help.


  • 2.  RE: INDs for Different Formulations

    This message was posted by a user wishing to remain anonymous
    Posted 14-Feb-2019 09:54
    This message was posted by a user wishing to remain anonymous

    I would leave it "as is". In your situation, I assume that both formulations (technically speaking both "dosage forms"), targeting the same indication. Correct? or this must be a bio study trying to determine the best formulation to move forward based on the pk/pd etc results. If so, leave it as is.
    Original Message


  • 3.  RE: INDs for Different Formulations

    Posted 14-Feb-2019 10:04
    If you put information for both formulations in the same IND then you are find.  many times they allow this in a single IND if you are studying the same indication/patient population.  Wen you file a marketing application you will likely need to file 2 NDAs.

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    Michael Hamrell, Ph.D., RAC, FRAPS
    Huntington Beach CA
    United States
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    Original Message


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