ADME In Vitro Programs
Total Antioxidant Activity Screening | Cell & Enzyme-Based Assays
Preclinical Evaluations Guiding First-in-Human Trials and Supplementing Clinical Metabolism & Drug-Drug Interaction Data.
ADME, toxicology, DMPK, and DDI in vitro studies are recommended by regulatory authorities to precede first in-human clinical trials or to supplement clinical metabolism or drug-drug interaction data.
Our Approach to In Vitro ADMET, DMPK, & DDI Programs
We take a collaborative approach to designing and implementing in vitro research programs. Our assays provide reliable prediction of the metabolism, and pharmacokinetic properties of a drug and potential for drug-drug interactions .
Each project is assigned to an experienced team that will design, implement, and interpret the study results. We provide consulting support to ensure that study results can be used for your R&D programs and regulatory submissions, and meet the needs of your internal and external stakeholders. We view our clients as partners and have structured our processes to be flexible and adaptable to meet changing project requirements, and at the same time, ensure that we provide high-quality deliverables on time and within budget.
ADME, toxicology, DMPK, and DDI in vitro studies are recommended by regulatory authorities to precede first in-human clinical trials or to supplement clinical metabolism or drug-drug interaction data.
In Vitro Services for Preclinical Drug Development
Antioxidant Assays
Antioxidant assays measure how well compounds or extracts protect against oxidative stress caused by reactive oxygen species (ROS). BioIVT offers cell-based and enzyme-based assays to evaluate antioxidant activity for use in drug development, personal care, nutrition, and therapeutic research.
Drug Metabolism
Drug metabolism studies profile metabolic pathways and likely metabolites formed by a compound, as well as identify drug-metabolizing enzymes involved in biotransformation.
Drug Transport
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.
Enzyme Induction
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.
Enzyme Inhibition
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.
Hepatobiliary Disposition
Hepatobiliary Disposition evaluate transporter-mediated efflux uptake. Our novel B-CLEAR study method design enables us to quantitate biliary versus basolateral efflux and provide an in vitro-relevant estimate of hepatic disposition.
Hepatotoxicity
Hepatotoxicity assays evaluate and predict hepatotoxic effects of test articles determine the dose range in other in vitro programs. We provide numerous models and recommend the optimal approach based on your research objectives and characteristics of the compound.
Supporting Assays
- Cell Permeability screening assays allow early prediction of intestinal absorption, blood-brain barrier penetration, and tissue distribution. These assays provide quick, low-cost data to better understand permeability properties of a compound.
Plasma Protein Binding (PPB) determines free drug concentration (fraction unbound,) 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.
Red Blood Cell (RBC) Partitioning studies determine your drug’s blood to plasma ratio. Some drugs have a tendency to bind to red blood cells or become sequestered through passive diffusion into the cells. Evaluating potential drug sequestration in red blood cells in addition to plasma protein binding studies helps to prevent misinterpretation of pharmacokinetic data and the potential overestimation of a drug’s intrinsic clearance.
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.