Malmfors Torbjörn, Di Marco Peter, Savolainen Kai
Malmfors Consulting AB, Karlskronavägen 22, S-121 52 Johanneshov, Vastmannagatan 48, 11325 Stockholm, Sweden.
Toxicol Lett. 2004 Jun 15;151(1):19-23. doi: 10.1016/j.toxlet.2004.02.016.
The intention of this proposal is to describe principles for Good Evaluation Practice (GEP) of toxicological and risk evaluations with the aim to improve the quality, reliability, and transparency of any evaluation in toxicology. The GEP has been outlined in the same way as the principles for Good Laboratory Practice (GLP) to facilitate its introduction and compliance. The main characteristic of GEP is transparency. The GEP procedure should include the following elements: (1) definition of terms; (2) description of evaluation organization; (3) description of the quality assurance of the programme; (4) description of the standard evaluation procedures; (5) performance of the evaluation; (6) reporting of the evaluation; (7) storage and retention of records and material; and (8) guidelines for the evaluation procedure. The authors' intent is to raise awareness, stimulate a debate about the proposal, expect and welcome feedback in order to refine it, and make it into an important tool for all toxicological evaluations in the future.
本提案旨在描述毒理学和风险评估的良好评估规范(GEP)原则,以提高毒理学中任何评估的质量、可靠性和透明度。GEP的概述方式与良好实验室规范(GLP)原则相同,以促进其引入和合规。GEP的主要特点是透明度。GEP程序应包括以下要素:(1)术语定义;(2)评估组织描述;(3)项目质量保证描述;(4)标准评估程序描述;(5)评估实施;(6)评估报告;(7)记录和材料的存储与保留;以及(8)评估程序指南。作者的意图是提高认识,引发关于该提案的辩论,期待并欢迎反馈以对其进行完善,并使其成为未来所有毒理学评估的重要工具。