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Harmonised high throughput microsomal stability assay.

Beth Williamson1, Claire Wilson2, Gayle Dagnell1

  • 1Evotec (UK) Ltd., 114 Innovation Drive, Abingdon, Oxfordshire OX14 4RZ, UK.

Journal of Pharmacological and Toxicological Methods
|November 7, 2016
PubMed
Summary
This summary is machine-generated.

A new high-throughput assay standardizes in vitro metabolic stability testing using hepatic microsomes from mouse, rat, and human. This consolidated assay ensures consistent prediction of hepatic intrinsic clearance (CLint) for drug discovery.

Keywords:
CYPClearanceIn vitroIn vivoScaling

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • In Vitro Assays
  • Pre-clinical Drug Development

Background:

  • Accurate prediction of human pharmacokinetics is crucial for drug discovery.
  • In vitro metabolic stability studies estimate in vivo hepatic intrinsic clearance (CLint).
  • Variability in laboratory protocols can impact data consistency.

Purpose of the Study:

  • To develop a harmonized, high-throughput assay for measuring CLint.
  • To consolidate diverse assay variables into a single, standardized format.
  • To ensure consistent and reliable in vitro CLint data across different species and conditions.

Main Methods:

  • Condensed numerous assay variables into a single harmonized format.
  • Evaluated compounds with diverse physicochemical properties.
  • Utilized mouse, rat, and human hepatic microsomes.

Main Results:

  • The consolidated assay format showed good correlation with traditional methods for human lots.
  • Consistent interpretation of in vitro CLint across different species strains was achieved.
  • Over 80% agreement was observed when comparing CLint across various conditions and species.

Conclusions:

  • A high-throughput assay was developed for simultaneous CLint measurement using mouse, rat, and human hepatic microsomes.
  • Condensing variables into one assay format yielded consistent data in head-to-head tests.
  • This standardized approach enhances data integrity for drug discovery.