Regulatory Open Forum

 View Only

  • 1.  IM to IV

    Posted 15-Dec-2021 13:09
    Hi All,

    I am Sangeeta Underwood, part of the team developing an IM formulation of a drug ultimately to be used in an autoinjector. Tmax obtained was on the high side. PK in animals and humans for IM formulation is poles apart. Planning on using the same formulation for IV after dilution. Would like input on what are the least amount of studies required for IV formulation in addition to tox studies in animals and  safety studies (Phase 1) in humans.

    ------------------------------
    Sangeeta Underwood

    ------------------------------


  • 2.  RE: IM to IV

    This message was posted by a user wishing to remain anonymous
    Posted 15-Dec-2021 16:45
    This message was posted by a user wishing to remain anonymous

    Are you developing an approved drug in new dosage form i.e. IM?

    Or is this a NCE ? developing first as a IM and then IV?
    Original Message


  • 3.  RE: IM to IV

    Posted 16-Dec-2021 14:12
    This is regarding NCE, developing first as a IM and contemplating to go for IV due to high Tmax (to achieve Cmax)  observed in Phase 1 study.

    ------------------------------
    Sangeeta Underwood
    Bioengineer
    Frederick MD
    United States
    ------------------------------

    Original Message


  • 4.  RE: IM to IV

    This message was posted by a user wishing to remain anonymous
    Posted 20-Dec-2021 10:40
    This message was posted by a user wishing to remain anonymous

    Thanks for providing additional clarification! Please be advised this is not a purely regulatory or QA question with text book style response rather its a drug development question involving a cross functional team with minimum clin pharm professional, CMC, and a senior level RA strategist. To really provide an appropriate response, one needs to know the results of your phase 1 study involving IM formulation, targeted therapeutic area/indication, and as well as your proposed IV formulation characteristics. If you don't take this seriously and go by what some CROs are recommending or any other professionals without asking to review the above information, you will end up doing more than necessary (i.e. you already have pk profile of your IM formulation) studies for IV or you may end up doing less than necessary. I'll reach out privately if you are interested and continue the discussion. Please advise.
    Original Message


  • 5.  RE: IM to IV

    Posted 20-Dec-2021 11:40
    Agree, this is more of a drug development issue. I am open to one on one discussion.




    Original Message


Related Content