“ADME” means “toxic pharmacokinetics”, which is the study of the body’s absorption, distribution, metabolism and excretion of foreign chemicals.
Medicilon Drug Safety Evaluation Service》》
Toxicokinetic absorption, distribution, metabolism, excretion
The toxicokinetic study adopts repeated administration toxicity test dose to study the dynamic change law of the drug in the body and obtain pharmacokinetic data. Usually combined with repeated administration 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 the safety to humans, the focus is on interpreting the results of toxicity tests and improving the value of safety evaluation data. The purpose of toxicokinetic studies 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 when exposed to humans.
At present, Medicilon Toxicity Test Center has carried out reproductive toxicity test (I, II, III), genetic toxicity test (Ames, micronucleus, chromosome aberration), local toxicity test, immunogenicity test, Studies on safety pharmacology, toxicokinetics, carcinogenesis, etc.
The main value of toxicokinetics research in safety evaluation is reflected in:
(1) Explain the systemic exposure of the test substance and/or its metabolites in the toxicity test and the dose and time relationship with the toxic reaction; evaluate the test substance and/or its metabolites in different animal species, gender, age, Toxic reaction of body state (such as pregnancy state); to evaluate the rationality of animal species selection and medication regimen in 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 is helpful to provide quantitative safety information for subsequent safety evaluation.
(3) Comprehensive efficacy, exposure, toxicity and exposure information to guide the design of human trials, such as initial dose, safety range evaluation, etc., and to guide clinical safety monitoring according to the degree of exposure.
• Plasma protein binding
• Tissue uptake
• Receptor properties
• Species differences in metabolic characteristics
• Pharmacological activity of metabolites
• Immunogenicity and toxicological effects
| Test type | Animal species | Type of drug | Route of administration | research content |
| Pharmacy / Toxicology | Mouse; Rat; Guinea Pig; House Rabbit; Beagle | 1. small molecules; 2. Biology; 3. Natural products; 4. Vaccine; 5. Chinese Medicine | 1. Oral: gavage, capsule; 2. Parenteral: intraperitoneal injection, intravenous injection, intramuscular injection, intradermal injection, subcutaneous injection, continuous infusion, intravitreal injection; 3. Others: nasal feeding, nasal cavity, eyes, rectum, vagina, implant | 1. Drug absorption, distribution, metabolism and excretion;PK/TK; 2. Bioequivalence; Bioavailability(po, sc, im, ip, etc.); 3. Organization Distribution; 4. PK/PD study of rodent disease model for dosage design and formulation of dosing schedule; 5. PK study of drug formulation development and evaluation; 6. Special PK studies, including food effects, gender factors, drug interactions and the impact of gastric juice pH on drug PK; 7. Plasma protein binding (equilibrium dialysis and ultrafiltration) |
• Design the dosing plan for 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 experimental reports based on complete toxicokinetic data
contact us: Email: marketing@medicilon.com
Phone: 021 58591500
Toxicokinetic Studies in Animals
marketing@medicilon.com
