Metabolism

Ou partner XenoTech has unparalleled experience and expertise in evaluating drug candidates as substrates, inhibitors and inducers of drug-metabolizing enzymes. They have a strong commitment to continuous systems improvement with the latest technologies, while ensuring the accuracy and reliability of the data generated.

To assess the victim and perpetrator potential of drug candidates, XenoTech conducts a variety of in vitro pre-clinical studies in accordance with the FDA's latest guidance (PDF).  They offer non-GLP studies as well as studies conducted in compliance with GLP regulations.

Although most of these studies are conducted on drug candidates, XenoTech has performed studies on other xenobiotics such as pesticides, cosmetics, fragrances, nutraceuticals and herbal preparations.

• Drug-Metabolizing Enzyme (DME) Inhibition
  Purpose: To assess the perpetrator potential of a drug candidate based on its ability to inhibit the metabolism of other drugs (an important cause of drug-drug interactions).
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• DME Induction
  Purpose: To assess the perpetrator potential of a drug candidate based on its ability to induce (up-regulate) the expression of DMEs and thereby increase the metabolism of other drugs (an important cause of drug-drug interactions). Read more
   
• Reaction Phenotyping (Enzyme Mapping)
  Purpose: To identify which enzyme or enzymes are responsible for metabolizing a drug candidate to assess its victim potential. Read more
   
• Species Comparison
  Purpose: To evaluate the metabolism (e.g., metabolic stability, metabolic profiling) of a drug candidate by subcellular fractions or isolated hepatocytes from human and toxicologically-relevant species. Read more
   
• Metabolic Stability
  Purpose: To assess the in vitro intrinsic clearance (Vmax/Km) of drug candidates to support lead candidate selection and species comparisons. Read more
   
• Metabolite Characterization and Identification
  Purpose: To assess pathways of metabolism to help determine an appropriate toxicological test species or to look for human-specific metabolites. Read more
   
• Toxicity in Primary Cultures of Human and Animal Hepatocytes
  Purpose: To evaluate the potential for liver toxicity (a major cause for withholding or withdrawing regulatory approval of drugs). Read more
   
  (Click here for more information):

  • Pharmacological Studies
  • Safety Studies
  • Clinical Studies
     

XenoTech scientists have delivered invited seminars, taught drug metabolism courses and consulted on metabolism-related issues for numerous organizations worldwide, including the FDA. They conduct studies following customized protocols, and have extensive experience in the preparation of customized reports for clients from all over the world. Non-GLP as well as GLP-compliant studies for FDA, EPA, MHLW and other submissions are offered.