Our Approach to Nonclinical ADME / DDI / DMPK Studies
SEKISUI XenoTech is a premier global provider of ADME/DMPK profiling studies utilized by 98% of the top pharmaceutical companies as well as numerous other companies and institutions.
As a leading contract research organization (CRO) in nonclinical drug development, we have unparalleled experience in evaluating drug candidates as substrates, inhibitors, and inducers of drug-metabolizing enzymes and drug transporters in both in vitro and in vivo experimental models to aid the prediction of drug behaviors in patients. Our US facility is famous for its role in revolutionizing DMPK research, and our Tokai facility has maintained a widely-respected foothold as a leading Japanese CRO for over 50 years, utilizing incomparable expertise in radioisotope (RI) synthesis services and streamlined study design.
Together, we offer a comprehensive suite of nonclinical services spanning the drug development pipeline– from preclinical screening through Phase II Clinical Trials. Our labs in both Kansas City, KS, and Tokai, Japan are world-renowned for providing our customers with expert guidance and assurance that every study is backed with our signature quality and care.
Preclinical Contract Research Services
Expert consultancy services provide clients with top-tier consultants and analysis on the critical components of absorption, distribution, metabolism, and excretion (ADME) and potential for drug-drug interactions (DDI) of their drug candidate. This input allows for the optimization of the data package for regulatory submission and minimizes the risk of costly or dangerous unexpected circumstances in clinical trials leading to late-stage failure.
In vitro ADME/DMPK/DDI studies are recommended by regulatory authorities worldwide to precede first in-human clinical trials or 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.
Nonclinical In vivo ADME/PK studies include IND-enabling animal studies through an AAALAC-accredited facility, providing context for bridging toxicology and pharmacology preclinical data as well as insight into ADME properties and metabolite formation with radioisotope (RI) labeled test article.
Bioanalysis involves quantitative measurement of small molecule drugs and/or metabolites of interest in plasma, tissue, or excreta with fit-for-purpose non-validated LC-MS/MS methods, allowing for fast turnaround times and accurate information.
Drug-drug interactions between biologic and small molecule drugs can result from an inflammatory response leading to elevated cytokine levels and subsequent suppression of drug-metabolizing enzymes such as cytochrome P450s (CYPs). We offer in vitro assays to evaluate the potential of a biologic drugs to cause a drug-drug interaction (DDI) directly or through cytokine effect on expression of drug-metabolizing enzymes and/or drug transporters.
Learn more about how our Contract Services fit into the landscape of preclinical drug development:
Read more about which in vitro and in vivo studies are needed for regulatory approval or watch a broad-strokes overview of how our services fit into the wide landscape of preclinical drug development in our ADME 101™ series.