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XenoTech has unparalleled experience and expertise in evaluating drug candidates as substrates, inhibitors and inducers of drug-metabolizing enzymes, and we pride ourselves on our outstanding record of client retention. We have a strong commitment to continuous improvement of our systems 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). We offer non-GLP studies as well as studies conducted in compliance with GLP regulations, and with our partnership with Sekisui Medical (SMD) ADME & Tox Research Institute, we are able to offer "one-stop shopping" for preclinical drug development services.
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.
- Enzyme 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).
- Enzyme 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).
- Reaction Phenotyping (Enzyme Mapping)
Purpose: To identify which enzyme or enzymes are responsible for metabolizing a drug candidate to assess its victim potential.
- 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.
- Metabolic Stability
Purpose: To assess the in vitro intrinsic clearance (Vmax/Km) of drug candidates to support lead candidate selection and species comparisons.
- 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.
- 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).
- Transporter Studies (XenoTech and SMD)
Purpose: To assess whether drug candidates are substrates for—or inhibitors of—P-glycoprotein (MDR1/ABCB1) and numerous other transporters involved in drug disposition. SMD offers the option of conducting these studies in compliance with GLP regulations.
- In Vivo Pharmacokinetic Studies (SMD)
Purpose: To determine the extent and rate of absorption, distribution, metabolism and excretion of a drug candidate administered to toxicologically-relevant species as well as a humanized animal (chimeric mice with humanized liver).
- Radiolabeled Compound Synthesis (SMD)
Purpose: To accelerate preclinical drug development, especially for in vivo pharmacokinetic studies using radiolabeled drug candidates.
- Screening Studies (SMD)
Purpose: To assess pharmacokinetic, pharmacological, physicochemical and toxicological properties for the optimization of lead compounds in early preclinical drug development.
- Other Services Available (SMD)
XenoTech scientists have delivered invited seminars, taught drug metabolism courses and consulted on metabolism-related issues for numerous organizations worldwide, including the FDA. We conduct studies following customized protocols, and we have extensive experience in the preparation of customized reports for clients from all over the world. We offer non-GLP as well as GLP-compliant studies for FDA, EPA, MHLW and other submissions.