GLP動物試驗的重要性與秀傳實驗動物中心GLP發展現況之概述

OVERVIEW OF THE DEVELOPMENT AND THE IMPORTANCE OF GLP (GRADE) ANIMAL TESTING AT SHOW CHWAN ANIMAL CENTER

黃志豪(Chih-Hao Huang) ； 程韻靜(Yun-Ching Cheng) ； 許素菁(Shu-Ching Hsu)

《秀傳醫學雜誌》 14卷3&4期 (2015/12) Pp. 119-125

https://doi.org/10.3966/156104972015121403007

摘要

隨著新興智能與知識日新月異的發展以及醫療保健需求科技化的期待，新藥開發與健康食品急速擴大之市場需求，台灣生技產業領域發展已進入活躍期。政府為能多方面投資與扶植相關產業更在北、中、南部皆成立相關生技園區。而利用實驗動物在藥品、健康食品甚至醫療器材產品研發等生技領域，特別是產品臨床前試驗的重要性日與俱增。有鑑於臨床前試驗之規格要求，台灣衛生福利部食品藥物管理署推動非臨床試驗優良操作規範（Good Laboratory Practice, GLP），係提供產品研發評估，做為產品查驗登記申請文件中的非臨床試驗應遵循之規範，以確保各項試驗數據之品質及試驗之完整性與可信度。因此秀傳實驗動物中心有別於傳統實驗動物中心之實驗動物科學應用與發展，目標將現有軟體與硬體重新規劃，並依據GLP規範進行內部調整，朝向GLP實驗動物中心發展。另因中心位於台灣生技醫藥產業鏈之中樞地帶，在地理優勢下，中心將以提供更高品質之臨床前試驗，來提升國內生技醫藥產業之產品驗證平台，進而促使台灣生技產業的發展與增加國外競爭力。

關鍵字

實驗動物中心 ； 非臨床前試驗優良操作實驗室 ； 安全性試驗

並列摘要

The development of Taiwan’s biotechnological industry has entered the active phase. Since 2010, bio-tech development has occurred in relevant biotechnology sectors and related industries in northern, central and southern parts of Taiwan. The status of animal experiments for Bio-tech companies is undeniable, particularly for development of pharmaceuticals, health food and even medical equipment as well as increasing clinical tests. Therefore, for preclinical trials in Taiwan, the TFDA promotes non-clinical trials by GLP to provide product research, development and identification. To ensure the integrity and credibility of the quality of the test data, the Show Chwan Animal Center is attempting to become a GLP grade animal facility rather than a traditional animal center. Our goals and functions are not just restricted to the common use of animal science but also to meet the needs for drug discovery and clinical applications. We will become qualified to support certification of product development for the biotechnology industry in the future.

並列關鍵字

epigenetics ； metabolic syndrome ； developmental programming ； maternal nutrition