In vitro ADME assays are used to profile the pharmacokinetic properties of a drug candidate. ADME stands for absorption, distribution, metabolism, and excretion. ADME assays provide essential insight regarding the metabolism and potential interactions of new drug compounds.
As the costs of bringing a new drug to market rise, ADME assays are an indispensable step in the drug development process. ADME-PK screenings reduce the potential for post-marketing drug withdrawals due to unforeseen issues by fully characterizing your drug candidates as early as possible.
Applications of In Vitro ADME Assays
The category of in vitro ADME includes a panel of in vitro assays that support companies seeking to characterize their compound with pharmacokinetic data. In vitro ADME assays in the hit-to-lead and lead optimization phases can help reduce failure rates in the future by providing accurate information on ADME, potential drug-drug interactions (DDIs), and unforeseen toxicities.
At IonTox, we offer a range of in vitro assays. Along with providing a detailed final report for each study, we will suggest follow-up studies to further your organization’s research goals.
This permeability assay predicts the intestinal permeability and oral absorption of your test compound. It’s required by the FDA for all companies applying for an Investigational New Drug (IND).
This test predicts the metabolic stability (half-life and clearance) of your compound. It’s a useful means of predicting the half-life and clearance of a test compound prior to in vivo testing.
The Cytochrome P450 (CYP) Induction assay predicts potential drug-drug interactions that can lead to toxicity or reduced efficacy. This assay meets the FDA guidelines on Drug Interaction Studies.
The Cytochrome P450 (CYP) Inhibition assay is another important test for predicting potential drug-drug interaction. It tests whether a compound will inhibit metabolism, which can lead to toxic accumulation.
Plasma Protein Binding
The Plasma Protein Binding Assay tests your compound’s ability to bind to plasma protein once it enters the bloodstream. This gives important insight into the distribution and bioavailability of your drug candidate.
The Protein Binding and Blood To Plasma Ratio Cell Partitioning Assay provides a comprehensive understanding of how the test compound interacts with whole blood and plasma proteins. This assay is most applicable when testing highly lipophilic compounds.
Evaluation of Transporter Interactions
This FDA-recommended evaluation tests how a new drug interacts with hepatic transporters. This screening reveals whether new drug candidates are substrates, inhibitors, or inducers of these important proteins.
Our Expertise at IonTox
IonTox is a biotechnology company specialized in providing in vitro toxicology services. By developing and furthering the field of in vitro technology, we aim to improve the methods for predicting human adverse effects from chemical exposure in the earliest stages of the drug discovery process.
Whether your company is seeking to achieve a successful regulatory submission or to further pharmacokinetic knowledge around a specific compound, we can provide guidance on the best path forward.
Contact us to consult on which in vitro ADME-PK assays are most applicable for your project.
In vitro ADME-PK services