Toxicity tests

  • 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.

  • Guideline

    OECD407、OECD408

    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

    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.

  • Guideline

    OECD 473

  • Test system

    Chinese hamster ovary cell

  • Test Aims

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

  • Guideline

    OECD 414、416

    TFDA 藥品非臨床試驗安全性規範

  • Test system

    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.

  • Test Aims

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

  • Guideline

    OECD 414、416

    TFDA 藥品非臨床試驗安全性規範

  • Test system

    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.

  • Test Aims

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