Drug-Drug Interaction Assays

Apredica offers drug-drug interaction assays in both screening and IND-enabling modes, and both with fast turnaround.

Contact us to learn more our drug-drug interaction testing services.

In September 2006 the FDA released a draft guidance for the drug industry: "Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling." In this guidance the FDA outlines the assays and methods recommended to determine the potential of drug candidates to cause drug-drug interactions. The main assays associated with drug-drug interactions are P-glycoprotein (P-gp) substrate or inhibition determination, CYP inhibition, CYP phenotyping, and CYP induction.

P-glycoprotein Assays:

• Active efflux determination in Caco-2 cells
• P-gp substrate determination in Caco-2 cells
• P-gp inhibition determination in Caco-2 cells

CYP Inhibition Assays:

• CYP Inhibition (Cyps 1A2, 2B6, 2A6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4 and 3A5). Both LC/MS/MS and fluorescent assay are available.
• CYP K_i Determination
• CYP Time-Dependent Inhibition (TDI)
• CYP K_I determination

CYP Induction Assays:

• CYP1A2 and CYP3A4 induction in human primary hepatocytes. Specific activity of the CYPs is measured relevant to controls.

CYP Phenotyping Assays:

• Characterization of which CYPs are metabolizing your compound is determined using either rCYP enzymes or 10 characterized individual donors.

Contact us to learn more about Apredica's drug-drug interaction studies.