Drug-Drug Interactions  (DDI)Specialist

Northeast US based drug sponsor in need of specialized expertise-

    • Not clinical DDI
    • Looking for someone who can advise on transporter studies (e.g., Cytochrome interactions)
    • In EU, requirements are different; FDA has recently updated their requirements; there is gray areas regarding what goes in their labels versus our labels
    • Looking for someone who can advise on those types of studies; currently studies going on in Europe and they get the data, so need to interpret what’s clinically relevant
    • CMO played this role in the past, but recently left
    • Project-based involvement, as needed (effort TBD) for at least 6 months

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