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Translation of in-vitro/non-clinical in-vivo to human ADME for subcutaneous formulations

  • 1.  Translation of in-vitro/non-clinical in-vivo to human ADME for subcutaneous formulations

    Posted 4 days ago

    Dear Colleagues,

    Does anyone have experience on the use of human in-vitro or animal in-vivo data and mechanistic models to predict human ADME performance in the context of bridging non-comparable subcutaneous drug products due to CMC changes (Biotherapeutics, Peptides, Oligonucleotides) during drug development? What approaches have you used and what has been your experience regarding regulatory acceptance to use this data with the goal to decrease or minimize the need of Bioequivalence and/or Relative Bioavailability trials? 

    Thanks for your help

    Elisa Oquendo



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    C. Elisa Oquendo Cifuentes
    Senior Research Fellow
    Boehringer Ingelheim Pharmaceuticals Inc
    Ridgefield CT
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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