Integrated Toxicokinetics (TK) Analysis

Pharmacokinetics (PK) studies typically evaluate drug absorption, distribution, metabolism, and excretion in healthy animals or early development. Toxicokinetics (TK) is conducted as part of regulatory toxicology studies and focuses on systemic exposure in the context of toxicity endpoints, supporting safety assessment and dose selection for clinical trials.

Where relevant, validated bioanalytical methods are developed to quantify major metabolites alongside the parent compound. TK parameters for metabolites are calculated separately to assess their contribution to overall exposure and potential toxicity. The scope of metabolite analysis is defined during study consultation.

We support rodent (rat, mouse) and non-rodent species (dog, cynomolgus monkey, minipig) commonly used in toxicology studies. Dosing routes include oral (gavage, capsule), intravenous, intraperitoneal, subcutaneous, and others as required. Specifics are scoped per project.

Yes. Our integrated approach includes correlation of TK parameters with histopathology, clinical chemistry, and organ weight data. This exposure-response analysis is a key component of the final TK report, helping to establish safety margins and inform regulatory submissions.

Our TK service supports a range of modalities, including small molecules, biologics, and antibody-drug conjugates (ADCs). For ADCs, we provide integrated TK analysis for total antibody, conjugated payload, and free payload, using appropriate bioanalytical platforms (LC-MS/MS and ligand binding assays as needed). Please confirm specific requirements during consultation.