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In Vitro ADME / DDI / DMPK Studies in Drug Development

ADME, 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.

Our Approach to In Vitro Studies Evaluating ADME / 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. Our lab 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.

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.

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In Vitro Services for Preclinical Drug Development

Drug metabolism studies profile metabolic pathways and likely metabolites formed by a compound, as well as identify drug-metabolizing enzymes involved in biotransformation.

Enzyme inhibition studies evaluate a compound’s inhibitory effect on drug-metabolizing enzymes to predict potential for drug-drug interactions that may increase toxicity or reduce therapeutic effect of concomitant medications.

Enzyme induction studies include in vitro and ex vivo experiments to predict a compound’s likelihood to increase clearance of a concomitant victim drug by up-regulating (inducing) enzymes that metabolize it.

Drug transport studies use regulatory agency-compliant test systems to investigate a compound’s potential to operate as a substrate or inhibitor of known uptake (SLC) and efflux (ABC) transporters, potentially precipitating a drug-drug interaction.

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.

Plasma Protein Binding (PPB) determines free drug concentration (fraction unbound, fu) in plasma, which is required to inform dosage considerations for the clinic and is a necessary input for several PK-related calculations, modeling, and definitive in vitro study design.

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.

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.

Optimize your in vitro studies

Find the right high-quality in vitro test systems and reagents for your in-house ADME/DMPK/DDI assays

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Scientific Content

Access ADME™ is constantly updated to equip you with a wealth of scientific resources covering a broad range of topics within nonclinical drug development

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