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In Vivo Toxicology Studies

Acute toxicity test

An acute toxicity test refers to the observation of toxic reactions within a certain period of time after animals are administered the test substance once or multiple times within 24 hours. The acute toxicity test mainly measures the median lethal dose (concentration), observes the acute poisoning performance, provides the acute toxicity data of the test substances, determines the toxicity mode and poisoning reaction, and provides the observation index and dose grouping for the subacute and chronic toxicity tests. 

Long-term toxicity tests

The long-term toxicity test (repeated dose toxicity test) refers to the toxic reaction caused by repeated exposure of animals to drugs and is the core content of non-clinical drug safety evaluation. The purpose is to study the target organs of the toxic effects of the test substance to study the dose-response (effect) relationship of the long-term toxicity of the drug, determine its LOAEL and NOAEL, propose the reference value of the safety limit of the drug, explore the possible mechanisms of toxic effects, determine the differences in toxic effects between species, provide a basis for extrapolating toxicity results to humans, predict possible adverse reactions to humans, and reduce the risk of medication for clinical subjects and users.

Toxicokinetic studies

Toxicokinetics is the study of the processes of absorption, distribution, metabolism, and excretion of drugs in greater than therapeutic doses in toxicological test animals and their dynamic changes over time under toxicity test conditions, describing the systemic exposure of compounds in animals and its relationship to toxicity study dose levels and toxicity study period.

Clinical and pathological studies in animals 

  • Hematology index

  • Biochemical indicators

  • Urinalysis indicators