Literature DB >> 19607869

Regulatory demands on data quality for the environmental risk assessment of pharmaceuticals.

A Küster1, J Bachmann, U Brandt, I Ebert, S Hickmann, J Klein-Goedicke, G Maack, S Schmitz, E Thumm, B Rechenberg.   

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.

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Year:  2009        PMID： 19607869     DOI： 10.1016/j.yrtph.2009.07.005

Source DB:  PubMed          Journal:  Regul Toxicol Pharmacol        ISSN： 0273-2300            Impact factor:   3.271


  6 in total

1.  Medicating the environment: assessing risks of pharmaceuticals to wildlife and ecosystems.

Authors:  Kathryn E Arnold; A Ross Brown; Gerald T Ankley; John P Sumpter
Journal:  Philos Trans R Soc Lond B Biol Sci       Date:  2014-11-19       Impact factor: 6.237

2.  Implementing ecopharmacovigilance in practice: challenges and potential opportunities.

Authors:  Gisela Holm; Jason R Snape; Richard Murray-Smith; John Talbot; David Taylor; Pernilla Sörme
Journal:  Drug Saf       Date:  2013-07       Impact factor: 5.606

Review 3.  Enhancing credibility of chemical safety studies: emerging consensus on key assessment criteria.

Authors:  James W Conrad; Richard A Becker
Journal:  Environ Health Perspect       Date:  2010-12-15       Impact factor: 9.031

Review 4.  A Critical Review of the Availability, Reliability, and Ecological Relevance of Arctic Species Toxicity Tests for Use in Environmental Risk Assessment.

Authors:  Rebecca J Eldridge; Benjamin P de Jourdan; Mark L Hanson
Journal:  Environ Toxicol Chem       Date:  2022-01       Impact factor: 4.218

5.  Criteria for Reporting and Evaluating ecotoxicity Data (CRED): comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies.

Authors:  Robert Kase; Muris Korkaric; Inge Werner; Marlene Ågerstrand
Journal:  Environ Sci Eur       Date:  2016-02-29       Impact factor: 5.893

6.  Biomonitoring of pesticides, pharmaceuticals and illicit drugs in a freshwater invertebrate to estimate toxic or effect pressure.

Authors:  Thomas H Miller; Keng Tiong Ng; Samuel T Bury; Sophie E Bury; Nicolas R Bury; Leon P Barron
Journal:  Environ Int       Date:  2019-05-01       Impact factor: 13.352
  6 in total

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