Toxicokinetic Studies – TK Studies

Toxicokinetics (TK) is a combination of pharmacokinetics and toxicology. Based on the principles and methods of pharmacokinetics, TK studies quantificationally discuss in vivo drug absorption, distribution, metabolism and excretion (ADME) under toxic doses in animals. Research of drug toxicity is helpful for understanding the drug target organs and provides the basis of drug clinical application and drug overdose diagnosis. Although increasing experiments are compliant with GLP standards to ensure the traceability of record and the reliability of results, some TK studies can’t compliant with complete GLP standards at early exploration stage. It is hard to be carried out in accordance with the established plan during the studies and there will always be a process of constantly adjusting. Therefore, GVK BIO provides exploratory non-GLP TK services involving several different strategies and depending on the scientific questions to be answered.

Our non-GLP protocols are simplified with template of study designs and corresponding abbreviated report format. We focus on preliminary evaluation of key endpoints and use more streamlined designs. Our streamlined processes mean less paperwork and more efficient data collection and review. We have flexible and dedicated staff to perform multiple functions resulting in simplified processes. Client interactions are simplified as well. Review cycles for protocol and report are reduced with preset study designs.

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