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工業技術研究院

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技術名稱: 化粧品原料、產品開發和評估、化學品和醫藥用品、醫療器材之安全性評估

技術簡介

2013年歐盟頒佈化粧品禁用動物測試,我國TFDA於2016.10宣布臺灣亦加入國際禁用化粧品動物測試。因此生醫所開始進行EPiTRIR人類表皮組織的研發,並以此元件開發替代動物實驗之皮膚刺激性&腐蝕性測試以及未來其他皮膚毒理&功能檢測之新替代方法和套組開發。該領域目前是全球熱門的生醫研究領域之一。

Abstract

2013 EU enacted new cosmetic regulatory to ban animal tests. 2016.10 Taiwan FDA also announced that Taiwan joined the international trend on ban of cosmetic animal testing. BDL began to develop EPiTRIR Human Epidermal Tissue and developed a new alternative to non- animal skin irritation and corrosive testing. Other new alternative skin toxicity and functional tests to animal experiments are also under development. The field is currently one of the world‘s hot biomedical research areas.

技術規格

此技術可作為化粧品原料、產品開發和評估、化學品和醫藥用品、醫療器材之in vitro安全性評估並可被國內外法規主管機關認可。

Technical Specification

This technology can be used as in vitro safety assessment method for cosmetics raw materials, product development and evaluation, chemical and medical supplies, medical equipments and can be recognized by domestic and foreign regulatory authorities.

技術特色

已經通過Phase 0, I, IIA, IIB的國際驗證,目前進行(Phase III)database 建立和驗證中。之後將進行peer review paper 撰寫、接著是邀請OECD委員來台。 EPiTRIR has passed Phase 0, I, IIA, IIB validation and is currently in its Phase III constructing database. Following will be the next completion of peer review paper, then will invite OECD members to Taiwan.

應用範圍

化粧品原料、產品開發和評估、化學品和醫藥用品、醫療器材之安全性評估

接受技術者具備基礎建議(設備)

細胞實驗操作設備

接受技術者具備基礎建議(專業)

細胞測試能力、品質系統

技術分類 醫藥技術

聯絡資訊

聯絡人:鄭興明 標靶藥物與傳輸技術組

電話:03-5732599 或 Email:shingcheng@itri.org.tw

客服專線:+886-800-45-8899

傳真:+886 3 5743964

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