This project has been archived.
Joint CPLG/DMLG Transporter Working Group
Drug-drug interaction data for transporter studies are sometimes hard to interpret and generalize for specific transporters because victims are frequently substrates of multiple transporters, inhibitors may inhibit multiple transporters and inhibition of metabolizing enzymes may also occur. Consequently, the need for and timing of clinical transporter DDI studies could benefit from additional scholarship.
Primary goals of the group are to collect both in vitro and clinical transporter data on member company drugs (both under development and approved) to probe the in vitro to in vivo correlation for transporter drug interactions including the overall magnitude of the interactions and the clinical implications, which would include refining the regulatory decision trees, trying to identify best practice (substrate and inhibitor), clinical impact, collection of regulatory interactions, and company experiences. This will involve the collection of clinical data, in vitro data for compounds that do and do not have clinical follow-up and regulatory questions involving transporter drug-drug interactions. The end goal is to produce position paper(s) for the purpose of educating our internal colleagues, regulatory authorities, and the broader scientific community. Secondary goals are to Investigate when permeability (or BCDDS classification) negates (or not) the need to perform transport assay’s for various transporters (main focus on intestinal, hepatic and renal); share potential best practices of in vitro models, including possible validations per company of assays or if assay data is translatable cross companies; and investigate the substrate dependency of transporter DDI’s.