“ADME” or “Toxicokinetics” is the process of studying the body’s absorption, distribution, metabolism, and excretion of foreign chemicals.
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
Species differences in metabolic characteristics
Pharmacological activity of metabolites
Immunogenicity and toxicology
Research content of pharmacokinetics and toxicokinetics:
|Test type||Animal species||Drug type||Route of administration||research content|
<Oral: gavage, capsule
| <Non-intestinal: intraperitoneal injection, intravenous injection, intramuscular injection, intradermal injection, subcutaneous injection, continuous infusion, intravitreal injection|
<Others: Nasal feeding, nasal cavity, eyes, rectum, vagina, implantation
| <drug absorption, distribution, metabolism and excretion|
<Bioavailability (po, sc, im, ip, etc.)
<PK/PD studies of rodent disease models for dose design and dosing regimens
<PK Research on Pharmaceutical Preparation and Evaluation
<Special PK studies, including food effects, gender factors, drug interactions, and gastric juice pH on drug PK
<Plasma protein binding (balanced dialysis and ultrafiltration)
- 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