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, 25 (1), 1-5

A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data

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A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data

H J Klimisch et al. Regul Toxicol Pharmacol.

Abstract

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.

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