Cytochrome P450 (CYP450) Inhibition Services

Advion Bioanalytical Labs' Cytochrome P450 (CYP450) inhibition study support provides in vitro drug interaction data of the highest quality utilizing validated LC/MS/MS assays with stable isotope-labeled internal standards.

Primary CYP450 inhibition study capabilities include:

  • Eight isoform-selective LC/MS/MS assays for seven human liver microsomal CYP isoforms:
    • 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4 (2 substrates)
  • Validated methodology utilizing stable isotope-labeled internal standards
  • Endpoints: percent inhibition; absolute or relative IC50

In addition, many aspects of our assays can be customized to provide our clients with the type of data and degree of quality assuredness that is required. Examples of assay specifics that are amenable to customization are as follows:

  • Flexible plate design: number of test compound concentrations and replicate reaction mixtures
  • Microsomal protein and substrate concentrations
  • Reaction time
  • Alternative control inhibitors
  • Extent of peer and quality assurance review

As with all of our services, we incorporate many measures in our CYP450 inhibition service offerings to ensure that the quality of our work exceeds client expectation. Such measures include the use of high purity substrates, control inhibitors, and reference compounds; carrying out the analyses to the standards of GLP; peer and QA review of study data; and adherence to the FDA Draft Guidance1 and PhRMA white paper2 on drug interaction studies.

We provide a core selection of assays, but also welcome the opportunity to work with our clients to develop and validate additional CYP isoforms or alternative substrates.

If interested in receiving more information about Advion's Cytochrome P450 (CYP450) Inhibition Services, contact clinical@quintiles.com.

Cytochrome P450 (CYP450) Inhibition Services overview sheet.

1. Guidance for Industry: Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling, USFDA, Draft Guidance, Sep 2006.

2. Bjornsson, TD et al. (2003) The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective. Drug Metab Dispos 31:815-832.