Title of article
Regulatory demands on data quality for the environmental risk assessment of pharmaceuticals
Author/Authors
Küster، نويسنده , , A. and Bachmann، نويسنده , , J. and Brandt، نويسنده , , U. and Ebert، نويسنده , , I. and Hickmann، نويسنده , , S. and Klein-Goedicke، نويسنده , , J. and Maack، نويسنده , , G. and Schmitz، نويسنده , , S. and Thumm، نويسنده , , E. and Rechenberg، نويسنده , , B.، نويسنده ,
Issue Information
روزنامه با شماره پیاپی سال 2009
Pages
5
From page
276
To page
280
Abstract
The evaluation of the quality of data and their use within the review of environmental risk assessment of human as well as veterinary pharmaceuticals is described from a regulatory point of view. A definition and differentiation in three categories for the reliability of data are given. Existing criteria relating to international testing standards for categorising reliability are adopted for their use within the environmental risk assessment of pharmaceuticals. A systematic documentation of evaluating reliability for literature data as well as for experimental studies (effect and environmental fate studies) is proposed. The data quality criteria are defined in order to increase the transparency of the evaluation process in Germany and thus the quality of the environmental risk assessment of pharmaceuticals.
Keywords
Environmental Risk Assessment , Pharmaceuticals , regulatory authorities , quality criteria
Journal title
Regulatory Toxicology and Pharmacology
Serial Year
2009
Journal title
Regulatory Toxicology and Pharmacology
Record number
1488704
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