Toxicokinetic (TK) testing

Assessment and characterization of biologic safety of large molecules

Toxicology (TK) is the branch of pharmacology that describes the behavior and effects of drugs at very high doses in preclinical studies. At these high concentrations, enzymes, transporters, and receptors become saturated, usually resulting in very different behavior and effects of the drug.

Pre-clinical Toxicokinetic (TK) studies have similarities with Pharmacokinetic (PK) studies, but have several key differences.  First, toxicokinetic studies are performed at much higher doses which allows for toxic affects to be more apparent. Secondly, TK studies are only conducted in animals rather than humans. Also, the end-point of a TK study is to determine the exposure levels at which toxic effects are observed and results are used to guide dosing recommendations for clinical testing. The objective of a PK study is to enhance drug efficacy by understanding clearance and the bioavailability of the drug within the biological system.

An expert TK service partner

We conduct our high-quality TK assay procedures and results strictly in compliance with GLP regulations and in accordance with international regulatory guidelines (FDA, EMEA, ICH). Measurement are performed using the bioanalytical platforms ELISA or Meso Scale Discovery (MSD).

Svar Bioanalytical Services are experts in bioanalysis for testing of large molecules. We use use a wide range of techniques and technology platforms to meet the needs of our customers and always work to optimize existing methods to increase efficiency and robustness.

Our agile, flexible team of scientists are continually developing and validating new methods and technologies to meet the ever-changing and increasing demand of our clients.

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