Common Biological Experiment Testing Items

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