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In Vitro Metabolic Stability Studies for Drug Discovery & Development

Metabolic stability studies in drug discovery and development assess the ability of a compound to be metabolized by enzymes through biotransformation. Measurement of intrinsic clearance rates can inform the pharmacokinetic profile of an investigative compound and allow drug developers to select an animal species with the closest metabolic profile to humans for nonclinical testing so as to better predict behavior in patients.

Metabolic stability assays give sponsors information about biotransformation in the liver or other sites of metabolism

Our Approach to Metabolic Stability Assays

Metabolic stability studies are not specifically required per regulatory guidance, but they can be helpful to identify appropriate species for nonclinical animal studies. Our contract service assesses the stability of a compound by measuring the disappearance of the parent compound in the selected in vitro test system.

  • LC-MS method development for analysis of test article
  • Triplicate measurements of compound incubated with an appropriate test system and cofactor at multiple time points.
  • Negative controls included are zero-time and zero-cofactor samples
  • A positive control substrate (e.g., 7-ethoxycoumarin, midazolam) is included to confirm metabolic competency of the test system
  • Tabular data summary

Test Systems We Offer (available in human and various animal species)

*Certain extrahepatic test systems may be available upon request.

Related Service: Metabolic Stability Screening

Discovery Plus™ Screening Suite presents medium-throughput alternatives to definitive metabolism & DDI studies through non-GLP, condensed versions of our definitive metabolic stability assays. This option is best used for comparison of multiple compounds or to yield preliminary data for definitive in vitro studies.

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Next Steps

What in vitro metabolism assays should you be planning next? Get an overview of regulatory expectations for in vitro DDI and metabolism data for IND

FDA approval map

Test Systems for Your Metabolic Stability Assays

Explore our extensive selection of characterized lots of cryopreserved hepatocytes, S9, and microsomes for your in-house studies

FindHuman liver microsomes or other test systems for in vitro drug metabolism testing