IND-Enabling Bundle of In Vitro Assays to Assess Drug-Drug Interaction Risk

DDI Fact Sheet

During development of new chemical entities (NCEs), an investigation into the likelihood of drug-drug interactions (DDI) is vital to the progression of these drug candidates. Possible drug-drug interactions can alter the pharmacokinetics of concomitantly administered medications, altering efficacy or toxicity. A definitive assessment of these risks should be performed early after selection of a lead candidate. Our scientists routinely evaluate these risks through validated, in vitro assays to determine the cytochrome P450 enzymes responsible for metabolism of NCEs and to assess the potential for NCEs to inhibit and/or induce these enzymes. These data will be included in the filing of the Investigational New Drug (IND) application to provide guideposts for clinical DDI assessments during the further development of drug candidates.

Contact us today to learn how we can help you determine any drug-drug interaction liability for your new drug/molecule.