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Common Biological Experiment Testing Items

2021-11-03
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Biological Test Items Under GLP Regulations:

  • Single and multiple dose toxicity test (rodent)

  • Single and multiple dose toxicity test (non-rodent)

  • Reproductive toxicity test (I, II)

  • Genetic toxicity test (Ames, micronucleus, chromosome aberration)

  • Local toxicity test (allergic, irritation, hemolysis)

  • Immunogenicity/Immune toxicology test

  • Safety pharmacology test Toxicokinetic test

Carry out systematic pharmacokinetic studies according to the requirements of the guidelines:

In Vivo Metabolism

  • Drug absorption, distribution, metabolism and excretion characteristics

  • Characterize the in vivo process and main pharmacokinetic parameters of the drug

  • Bioavailability

  • Bioequivalence

In Vitro Metabolism

  • Metabolic Stability of Humans and Animals,

  • Drug Metabolic Interactions,

  • Drug Transport Characteristics,

  • Plasma Protein Bound

  • Metabolite Analysis

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