Regulatory Open Forum

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  • 1.  End of Phase 2 Meeting

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jul-2019 16:07
    This message was posted by a user wishing to remain anonymous

    Dear Experts,

    There is an internal debate happening in my company regarding the mass balance study.  Should a sponsor have conducted the human mass balance study before the end-of-phase 2 meeting?

    Thank you for any advice - it is greatly appreciated.

  • 2.  RE: End of Phase 2 Meeting

    Posted 11-Jul-2019 12:03
    There is no regulation when this has to be done, but FDA recommends early in the development process:

    We encourage the identification of any differences in drug metabolism between animals used in
    nonclinical safety assessments and humans as early as possible during the drug development
    process.8,9 The discovery of disproportionate drug metabolites late in drug development can
    potentially cause development and marketing delays (from guidance on safety of metabolites)

    Personally, if choice, i would do before the EOP2 as one: may generate more questions that you need answered ( need for renal impaired studies, hepatic impairment studies) and 2) the answers you get for the questions you have now may not be relevant once you do your mass balance study.

    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    Auburndale MA
    United States