- Guideline
OECD423-Acute Oral toxicity
TFDA 藥品非臨床試驗安全性規範
- Test system
1) Rodents: a study of 6 months duration;
2) Non-rodents: a study of nine months duration.
- Test Aims
To test the acute toxic effects of substances in mammals after single dosing (including multiple dosing completed within 24 hours).
It can used to define a maximum tolerated dose, and the dose setting for Phase 1 clinical trials.