In Vitro CYP Induction (Definitive)

Overview

Sekisui XenoTech CYP enzyme induction studies can be designed to meet the needs of the client based on the criteria and recommendations of the FDA or EMA guidelines. Sekisui XenoTech maintains a minimum of three cryopreserved primary human hepatocyte lots that have been extensively characterized with a series of weak to strong CYP3A4 inducers to acquire a Relative Induction Score (RIS) for each individual lot. The use of these RIS characterized lots as the standard in Sekisui XenoTech enzyme induction studies allows clients to predict the magnitude of clinical DDI by CYP3A4 induction as necessary with the proper in vitro study design. Sekisui XenoTech's definitive CYP induction studies utilize either fresh or cryopreserved primary human hepatocytes.

We recommend the following study design to meet the EMA / FDA guidelines:
  • Cryopreserved primary human hepatocytes, RIS characterized
  • CYP1A2, CYP2B6, CYP3A4 mRNA expression by qRT-PCR
  • 6 - 8 concentrations of test article (how to choose your concentration range)
  • EC50 / Emax data
  • Vehicle control (test article solvent)
  • Negative control for induction (clinical and in vitro non-inducer)
  • Multiple positive controls (prototypical inducers)
  • Pre-study solubility testing
  • Spent media analysis with multiple time point collections as recommended by the EMA and FDA
  • Full submission quality report
  • Non-GLP

Study options to exceed the EMA / FDA guidelines:
  • CYP1A2, CYP2B6, CYP3A4 in situ based activity by a 2-step cocktail incubation
  • Microsomal based activity by single substrate incubation
  • Pre-induction study toxicity assessment
  • Full GLP Dose Solution Analysis on-site
  • CYP2C8, CYP2C9 and CYP2C19 activity and/or mRNA expression endpoints
  • Additional commercially available probes for mRNA expression endpoints (e.g., MDR1)
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<< Enzyme Induction
In vitro UGT Induction (Definitive)
In vitro Induction Express (Screening)
Ex vivo CYP and UGT Enzyme Induction
Cytotoxicity
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