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  • 1.  DS requirements for an IND

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jul-2019 09:11
    This message was posted by a user wishing to remain anonymous

    How much DS stability data is required for an IND for a biologic in oncology? The FDA agreed to our plans to file based on 1 month DP stability data with additional GLP DP stability data. Now we're wondering how much of the DS stability data is required to be shown. The issue is the timeline not the substance of the data to ensure we are able to file when planned.
    Thanks for any guidance.


  • 2.  RE: DS requirements for an IND

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2019 09:11
    This message was posted by a user wishing to remain anonymous

    ​You would need enough stability data to support the length of time between manufacture of the DS and when it gets used in the DP. For instance if you manufactured DS in January and you made the DP 2 months later, you would need at least 2 months stability for the DS.
    Original Message


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