IVAL's products and contract services represent three decades of expertise in the application of in vitro experimental systems to evaluate drug absorption, metabolism, transporters, drug-drug interactions and drug toxicity. We focus on hepatocytes as a preferred test system, including co-cultures between hepatocytes and other relevant cell types to suit each investigative purpose.
In addition to the broadly available “routine” in vitro ADME studies, we have also developed higher throughput screening assays to aid the selection of best drug candidates for during early phases of drug development.
We support a collaborative research environment, and appreciate receiving feedback from you on how to meet your needs, whether it's through contract services, hepatocytes, or training / education.
Predicting the potential for drug-drug interactions with co-administered compounds starts by understanding the metabolic pathway by which a compound is eliminated from the body. Compounds with a single route of elimination are at high risk of causing adverse events. To obviate any dangerous polypharmacy situations in patients, identifying the metabolic pathway(s) of a drug candidate is required by regulatory agencies prior to IND submission.
These studies are performed using liver microsomes in the presence of selective inhibitors for the major CYP isoforms, thus identifying the metabolic routes involved. Quantification of the parent compound and its metabolites are performed using HPLC-LC/MS, and the percent contribution of a specific CYP isoform towards metabolism of the test article is reported.
Primary hepatocytes are widely used in evaluating metabolism, drug-drug interactions, drug transporter activity, and potential toxicity of drug candidates. As a CompleteHepatocyteSolutionTM company, our goal is to provide hepatocytes of the highest quality to ensure our customers can produce reliable, consistent data. With IVAL, you aren’t restricted by a pre-set isolation calendar—let us know when you need a fresh hepatocyte preparation and we’ll prepare it to fit your schedule.
Metabolic Stability is a key drug property. It is important for drug administration regimen design as well as toxicity. Species comparison in metabolic stability allows the determination of which animal species is the most appropriate model to estimate human metabolic stability. The use of human primary hepatocytes allows the evaluation of metabolic stability as a result of both phase I oxidation and phase II conjugation.
In vitro testing using primary cells can quickly screen for new chemical entities with serious toxicology consequences. Using primary cells derived from human tissues, the relative risk can be determined in multiple organs over a population of donors.
The following in vitro cytotoxicity assays using the specified endpoints have been developed in our laboratory. With our ready inventory of human and cynomolgus monkey cells scheduling is not an issue. Contact us to customize your study today.
Pravastatin Uptake Assessment: 96 well cultures at a cell density of 0.5 million hepatocytes/mL (50,000 hepatocytes/well) were used in the Pravastatin Uptake Assessment. After approximately 20-24 hours in culture, the hepatocytes were treated with 1 µM of Pravastatin with and without Rifampin for a time duration of 0,1, 2, 3, 4, and 5 minutes. Values reflect the mean of triplicate treatments (N=3). The metabolites were identified and analyzed using LCMS/MS.
Transporter & Cell Uptake Assays Services
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