Toxicokinetic test is to use the principles and methods of pharmacokinetics to quantitatively study the absorption, distribution, metabolism, excretion process and characteristics of drugs in animals under toxic doses, and then explore the law of the occurrence and development of drug toxicity. Understand the distribution of drugs in animals and their target organs.
The process by which the compound enters the animal and the animal's response to the compound when the administered dose exceeds the therapeutic dose. Like pharmacokinetics, it also needs to go through four steps of absorption, distribution, metabolism and elimination.
There are many factors that affect the toxicity of a compound, but most of them are related to the toxicokinetics of the compound, including residence time and concentration at the site of administration, rate and total amount of compound absorbed, distribution of the compound in the body, and its distribution in organs. Concentration, etc., rate of metabolism, nature of metabolites, total amount and duration of compounds or their metabolites in body tissues, and rate and manner of excretion of compounds.
For innovative drugs, toxicokinetics research has obvious value in the following aspects:
1. Describe the systemic exposure of the drug in the toxicity test and the relationship between dose and time;
2. Describe the effects of repeated doses of extension of exposure on metabolic processes, including effects on metabolic enzymes (such as induction or inhibition of drug-metabolizing enzymes);
3. Explain the toxicological findings or changes of the drug in the toxicity test. Evaluate the toxicity of drugs in different species, gender, age, and physical conditions such as disease or pregnancy, and support animal species selection and drug regimens for non-clinical toxicity studies;
4. Analysis of the value of animal toxicity performance in clinical safety evaluation, such as liver toxicity or kidney damage caused by drug accumulation, can provide information for subsequent safety evaluation;
5. Toxicology tests combined with toxicokinetic studies can provide more sufficient information support for non-clinical studies, such as clinical phase I dose selection, dose exploration tests, toxicity reactions and their severity analysis, etc.;
6. In some cases, a short-term subacute toxicity test (1-3 months) accompanied by a toxicokinetic study can better support the drug's entry into early clinical trials, help reduce the safety risks of clinical trials, and help shorten the duration of the drug. research period.
Purpose
To provide the basis for further other toxicity tests, and to provide the basis for the diagnosis and treatment of clinical drug use and drug overdose in the future.
AxisPharm offers full service of toxicokinetic study in mouse, rat, dog, monkey, and etc. We also perform the bioanalysis of toxicology samples from other contract labs.
Article source: https://article-realm.com/article/Health-Fitness/Exercise/30001-The-Value-of-Toxicokinetic-Research-in-Innovative-Drug-Research.html
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