ADME, toxicology, DMPK, and DDI in vitro studies are recommended by regulatory authorities worldwide to precede first in-human clinical trials or to supplement clinical metabolism or drug-drug interaction data. Cell-based assays can provide reliable prediction of a drug’s metabolism, pharmacokinetic properties, and potential for drug-drug interaction within a patient.
In Vitro ADMET / DDI / DMPK Studies in Drug Development
Our Approach to In Vitro Studies Evaluating ADMET / DMPK / DDI
We are the metabolism and DDI experts, trusted by 98% of top pharma for reliable, quality data from predictive DMPK assays.
Our scientists value speed, service, and superiority and take a thorough, consultative approach to all in vivo and in vitro studies. SEKISUI XenoTech was founded more than 25 years ago by a few scientists at the University of Kansas studying the intricacies of drug metabolism and our expertise has been growing ever since, into a comprehensive suite of nonclinical offerings to enable and support clinical development of new drugs. Together with the Drug Development Solutions Center, we can provide reliable, high-quality studies to help you meet regulatory expectations and understand your molecule.
The greatest strength of SEKISUI XenoTech is their reputation for quality, attention to detail, quality of reports. When it comes to DMPK running assays that are compliant, they have established a good reputation. When you want to make sure something is done right they are often the first one thought of. Initially we contracted with another vendor, but we got concerned about their quality and customer service, and then we came back to SEKISUI XenoTech.Large Pharma Customer, Pharma Chief Development Officer
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In Vitro Services for Preclinical Drug Development
Discovery Plus™ screening suite provides fast, non-GLP data useful in planning definitive in vitro studies or providing preliminary ADME data to select the right compound to carry forward through development. Options include enzyme inhibition & induction, metabolic stability, permeability, plasma protein binding, and transporter inhibition.
Lysosomal trapping is a physicochemical (non-enzymatic and non-transporter mediated) process by which membrane-bound organelles within hepatocytes can sequester lipophilic amine drugs, potentially limiting clearance and reducing therapeutic effect. We offer screening and mechanistic determination assays to predict propensity for trapping.
Pharmacology & Receptor Binding Services include RadioReceptor Binding and a panel of over 230 validated in vitro pharmacological assays covering a broad range of targets including receptors, transporters, enzymes, ion channels and second messengers to assess pharmacological safety parameters for small molecule drugs.
Hepatotoxicity evaluation services help sponsors in Drug Discovery & Developent to investigate drug candidates for charcteristics associated with risk of drug induced liver injury (DILI). Through the Drug Development Solutions Center, we offer Cholestatic DILI assessments, Mitochondrial Toxicity, Covalent Binding, Reactive Metabolite Identification, and Acyl Glucuronide Formation studies. These assays can contribute to a comprehensive DILI risk profile.
For GLP (Good Laboratory Practices) studies, solutions containing specific concentrations of the drug molecule applied to the test system need to be analyzed for accurate and precise measurement of the drug compound. Our analytical services department can develop methods for accurate and precise quantification in compliance with regulatory requirements.