CYP450 Inhibition Services

Expanding upon the success of Advion’s other LC/MS/MS services, we also offer cytochrome P450 (CYP450) inhibition services. Utilizing validated LC/MS/MS assays with stable-label internal standards, Advion’s CYP450 inhibition study support provides in vitro drug interaction data of the highest quality.

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. Primary 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-label 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:

• Number and replicates of test compound concentrations (flexible plate design)
• Microsomal protein and substrate concentrations
• Reaction time
• Alternative control inhibitors
• Extent of peer and quality assurance review

If interested in receiving more information about Advion's CYP450 Inhibition Services, contact info@advion.com.

Click here for a copy of our 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for Industry: Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling, USFDA, Draft Guidance, Sep 2006.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.