Toxicokinetics Test Service Company

“ADME” or “Toxicokinetics” is the process of studying the body’s absorption, distribution, metabolism, and excretion of foreign chemicals.

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Toxicokinetic absorption, distribution, metabolism, excretion

The toxicokinetics study used repeated doses of the toxicity test dose to study the dynamic changes of drugs in vivo, and obtained pharmacokinetic data. It is usually carried out in conjunction with repeated administration of toxicity tests. If appropriate parameters are determined, repeated tests can be avoided. Toxicokinetics is an integral part of the design of non-clinical trials. In understanding the results of toxicity studies and comparing them with clinical data to evaluate safety for humans, the focus is on interpreting the results of toxicity tests and increasing the value of safety assessment data. The purpose of the toxicokinetics study is to know the degree and duration of systemic exposure of the test substance at different dose levels in the toxicity test, and to predict the potential risk of the test substance in human exposure.

At present, the Medicilon Toxicokinetics Test Center has carried out comprehensive reproductive toxicity tests (paragraphs I, II, III), genotoxicity tests (Ames, micronucleus, chromosome aberrations), local toxicity tests, immunogenicity tests, Studies on safety pharmacology, toxicokinetics, carcinogenesis, etc.

The main values of toxicokinetics research in safety evaluation are:
(1) Describe the systemic exposure of the test substance and/or its metabolites in the toxicity test and its dose and time relationship with the toxic reaction; evaluate the test substance and/or its metabolite in different animal species, sex, age, Toxicity of body status (eg pregnancy status); Evaluate the rationality of animal species selection and medication regimen for non-clinical toxicity studies.
(2) Improve the predictive value of animal toxicity test results for clinical safety evaluation. Evaluating the target site toxicity (such as liver or kidney toxicity) caused by the accumulation of the test substance based on the exposure amount helps to provide quantitative safety information for the subsequent safety evaluation.
(3) Comprehensive drug efficacy and exposure and toxicity and exposure information to guide the design of human trials, such as initial dose, safety range evaluation, etc., and guide clinical safety monitoring according to the degree of exposure.

Exposure Assessment Services

Plasma protein binding
Tissue uptake
Receptor properties
Species differences in metabolic characteristics
Pharmacological activity of metabolites
Immunogenicity and toxicology

Research Content of Pharmacokinetics and Toxicokinetics:

Our Staff

Design the dosing regimen of the toxicokinetic test
Collect samples in time according to the frequency required for exposure assessment
Analysis of analyte and biological matrix (biological fluid or tissue)
Data statistics and evaluation
Write an experimental report based on complete toxicokinetic data

Phone: 021 58591500

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What is Toxicokinetics?

What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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