Klimisch H J, Andreae M, Tillmann U
BASF Aktiengesellschaft, Ludwigshafen, Germany.
Regul Toxicol Pharmacol. 1997 Feb;25(1):1-5. doi: 10.1006/rtph.1996.1076.
The evaluation of the quality of data and their use in hazard and risk assessment as a systematic approach is described. Definitions are proposed for reliability, relevance, and adequacy of data. Reliability is differentiated into four categories. Criteria relating to international testing standards for categorizing reliability are developed. A systematic documentation of evaluating reliability especially for use in the IUCLID database is proposed. This approach is intended to harmonize data evaluation processes worldwide. It may help the expert in subsequent assessments and should increase the clarity of evaluation.
本文描述了作为一种系统方法的数据质量评估及其在危害和风险评估中的应用。提出了数据可靠性、相关性和充分性的定义。可靠性分为四类。制定了与用于对可靠性进行分类的国际测试标准相关的标准。提出了一种系统的可靠性评估文档,特别是用于IUCLID数据库。这种方法旨在使全球的数据评估过程协调一致。它可能有助于专家进行后续评估,并应提高评估的清晰度。