In Vitro ADME Services

Characterization of a chemical series or drug candidate's ADME properties and its potential for drug interactions is best when determined early. This helps to de-risk candidate molecules and improve project productivity through more targeted chemical synthesis and progression of the right compounds


2020 FDA In Vitro Drug Interaction Study Guidance

The 2020 FDA guidance document entitled In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry is the final guidance as of January 2020 intended to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product.

The guidance focuses on in vitro approaches to evaluate the interaction potential between investigational drugs with cytochrome P450 enzymes (CYPs) and transporters and how the results can inform future clinical DDI studies.
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In Vitro ADME Assays

Many of our in vitro ADME assays have multiple formats available to suit the different stages of the drug discovery and development pipeline, providing a flexible approach to ADME screening. Choosing from a range of formats, we can select the assays that best meet your throughput, data resolution, and quality needs and achieve your project specific goals.

Below is a list of our in vitro ADME screening assays.

Delivering Data In Vitro ADME Assays “Even Faster”

Watch this webinar titled Enabling DMPK Science: Delivering In Vitro ADME Data “Even Faster” to learn how in vitro data is used for many purposes during the drug discovery and development stage to triage and prioritize NCEs to enable in vivo PK, PK/PD, efficacy and TK studies. Learn how Charles River in vitro ADME scientists provide necessary data to establish insight into the key physicochemical properties and structural motifs, ensuring the efficacy and safety of compound candidates.

Learn how data from in vitro ADME assays are used to triage and prioritize NCEs to enable in vivo PK, PK/PD, efficacy and TK studies.

Watch the webinar


Frequently Asked Questions (FAQs) for In Vitro ADME Assays

  • Why are in vitro ADME assays important?

    As compound potency improves during hit-to-lead and lead optimization, in vitro ADME and DMPK assays provide necessary data to establish insight into the key physicochemical properties and structural motifs, ensuring the efficacy and safety of compounds.

  • Does Charles River offer services for custom in vitro ADME assays?

    Yes, while standard protocols help to maximize throughput and reduce lead times, Charles River can assist in customizing a comprehensive strategy that provides the targeted candidate ADME profile.

  • How does Charles River determine physicochemical properties?

    Kinetic solubility interprets the performance of compounds within in vitro ADME assays and biology screens while also assessing the effect the structural modifications have upon solubility within chemical series. Experimental logP/logD assessments are also available using miniaturized shake-flask methodology to reinforce in silico predictions.

  • What methodologies does Charles River use to determine metabolic stability for in vitro ADME assays?

    Charles River uses validated metabolic stability screens to assess a compound’s vulnerability to metabolic instability whether through CYP450-mediated or other types of oxidations, conjugations or other biotransformations. High resolution mass spectrometry is used to identify putative metabolites, elucidate their structures, and characterize the metabolic fate of compounds.