Benefit from our ultra sensitive pharmacokinetic (PK) bioanalytical sample testing
Ultra sensitive bioanalytical support for modern biotherapeutics throughout the phases of drug development.
Combining broad quantitative range with excellent sensitivities, we are able to support biologics PK using a single assay format. From high dosing in TOX through extreme low dosing in dose-escalation to the later clinical stage, we provide regulated PK sample testing using validated methods, based on the same assay. This eliminates the need to run several assays to pair sensitivity and range.
Our immunoassay validation is carried out as detailed by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines for Bioanalytical Method Validation.