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Dose Ranging and Proportionality

Toxicokinetic (TK) is an interdisciplinary subject that applies the principles of pharmacokinetics to study the occurrence and development of toxicity or adverse effects of drugs and other exogenous chemicals. It uses the principles and methods of pharmacokinetics to quantitatively study the process and characteristics of absorption, distribution, metabolism and excretion (ADME) of toxic substances in animals at toxic doses, and to explore the regularity of occurrence and development of toxicity, so as to provide a scientific basis for toxic safety evaluation.

For innovative drugs, the study of toxicokinetic is of obvious value in the following aspects:

·Describe the whole-body exposure and dose to time relationship in the toxicity test.

·Describe the effects of extended exposure on metabolic processes, including the effects on metabolic enzymes (e.g. induction or inhibition of drug metabolic enzymes).

·Explain the toxicological findings or changes of drugs in toxicity tests. To evaluate the toxicity of drugs in different genus, sex, age, physical condition, such as disease or pregnancy, and to support the selection of animal genus and drug regimen for non-clinical toxicity studies.

·Analyzing the value of animal toxicity manifestations in clinical safety assessment, such as hepatotoxicity or kidney damage caused by drug accumulation, can provide information for subsequent safety assessment.

·Toxicological tests combined with toxicokinetic studies can provide more information support for non-clinical studies, such as clinical phase I dose selection, dose exploratory tests, toxic reactions and severity analysis, etc.

·In some cases, short-term subacute toxicity tests (1-3 months) accompanied by toxicokinetic studies can better support the innovative drugs entering into early clinical trials, help to reduce the safety risk of clinical trials, and help to shorten the drug development cycle.

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