OECD423-Acute Oral toxicity

TFDA 藥品非臨床試驗安全性規範

1) Rodents: a study of 6 months duration;

2) Non-rodents: a study of nine months duration.

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.

OECD407、OECD408

TFDA 藥品非臨床試驗安全性規範

1) Rodents: a study of 6 months duration;

2) Non-rodents: a study of nine months duration.

The test substance is orally administered daily in graduated doses to several groups of experimental animals, one dose level per group . During the period of administration the animals each day for signs of toxicity.

OECD 473

Chinese hamster ovary cell

The purpose of the in vitro chromosome aberration test is to identify agents that cause structural chromosome aberrations in cultured mammalian somatic cells.

OECD 414、416

TFDA 藥品非臨床試驗安全性規範

The preferred rodent species is the rat and the preferred non-rodent species is the rabbit. Justification should be provided if another species is used.

The test of reproduction to provide general information concerning the effects of a test substance on male and female reproductive performance in different period.

OECD 414、416

TFDA 藥品非臨床試驗安全性規範

The preferred rodent species is the rat and the preferred non-rodent species is the rabbit. Justification should be provided if another species is used.

The test of reproduction to provide general information concerning the effects of a test substance on male and female reproductive performance in different period.

OECD 414、416

TFDA 藥品非臨床試驗安全性規範

The preferred rodent species is the rat and the preferred non-rodent species is the rabbit. Justification should be provided if another species is used.

The test of reproduction to provide general information concerning the effects of a test substance on male and female reproductive performance in different period.

OECD 404: Acute Dermal Irritation/Corrosion

Rabbits

Corrosion/irritation likely to arise from exposure to liquid or solid test substance by dermal application.

OECD406 Skin Sensitisation

TFDA 藥品非臨床試驗安全性規範

Guinea pig

Confirm whether the substance will cause exert skin sensitization in guinea pigs.