General Toxicology

We have an experienced team of toxicology specialists and a team of highly qualified experts—both domestic and international—who can provide clients with scientifically sound study designs and dose selections to ensure the smooth conduct of toxicology studies. Our general toxicology studies comply with international GLP regulatory standards, and our study designs meet the requirements of relevant guidelines issued by the NMPA (CFDA), U.S. FDA, OECD, and ICH, enabling us to satisfy the requirements for clinical trial applications or market approvals in various countries and regions.

General Toxicology

We have an experienced team of toxicology specialists and a team of highly qualified experts—both domestic and international—who can provide clients with scientifically sound study designs and dose selections to ensure the smooth conduct of toxicology studies. Our general toxicology studies comply with international GLP regulatory standards, and our study designs meet the requirements of relevant guidelines issued by the NMPA (CFDA), U.S. FDA, OECD, and ICH, enabling us to satisfy the requirements for clinical trial applications or market approvals in various countries and regions.

 

Type of experiment

 

• Dose-ranging study

• Single-dose toxicity test

• Repeated-dose toxicity study with toxicokinetics (1/3/6/9 months)

• Allergy test:

- Active systemic allergy test, passive skin allergy test, active skin allergy test, and photoallergy test

- Guinea pig maximization test, closed patch test, and mouse local lymph node assay

• Hemolytic assays: in vitro hemolysis assays and in vivo hemolysis assays in animals

• Local irritation tests: vascular, skin, mucosal, and muscle irritation tests

• In vivo phototoxicity test

• In vitro phototoxicity assay (3T3 cells)

• T-cell-dependent antibody response assay

 

Test animal species

 

Mouse, rat, guinea pig, rabbit, dog, non-human primates (crab-eating macaque, rhesus monkey), miniature pig, golden hamster, immunodeficient mice

 

Route of administration

 

Oral (gavage, capsules), nasogastric feeding, topical application to skin and mucous membranes, intravenous (bolus injection, continuous infusion)

Subcutaneous, intradermal, and intramuscular injections

Intravenous, intra-articular, vaginal, rectal, intracranial, and intratumoral injections