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Reporting and evaluating ecotoxicity data
MistraPharma researchers Marlene Ågerstrand and Christina Rudén at KTH, together with colleagues at Stockholm University and the German Federal Environment Agency, have published two papers on the reporting and evaluation of ecotoxicity data.
Comparison of four different methods for reliability evaluation of ecotoxicity data - A case study of non-standard test data used in environmental risk assessments of pharmaceutical substances.
Ågerstrand M, Breitholtz M and Rudén C (2011) Environ Sci Eur 23: 17. Read article
 
This paper addresses the fact that standard (guideline) test data are still preferred and recommended for regulatory environmental risk assessments of pharmaceuticals even though data generated by non-standard tests could improve the scientific basis of risk assessments by providing relevant and more sensitive endpoints.
 
In this paper it is explored if non-standard ecotoxicity data can be evaluated systematically in risk assessments of pharmaceuticals. This is done by evaluating the usefulness of four reliability evaluation methods, and by investigating whether recently published non-standard ecotoxicity studies from the open scientific literature fulfill the criteria that these methods propose.
 
This effort shows that the four evaluation methods come to different conclusions about the reliability of the selected data in seven out of nine cases. An additional finding is that the selected non-standard test data were considered reliable/acceptable in only 14 out of 36 cases.
 
It is concluded that the four evaluation methods differ in scope, user friendliness, and how criteria are weighted and summarized. This affected the outcome of the data evaluation. The results suggest that there is room for improvements in how data are reported in the open scientific literature.

 
Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals.
Ågerstrand M, Küster A, Bachmann J, Breitholtz M, Ebert I, Rechenberg B and Rudén C (2011)Environmental Pollution, in press. Abstract

In this paper a new set of reporting and evaluation criteria for ecotoxicological experiments is proposed and discussed. The new set of criteria has been generated by combining and developing approaches previously proposed in the literature and in the OECD reporting requirements. There are three main purposes of this work: (1) to encourage researchers to report their ecotoxicological studies in a more standardised way, (2) to introduce a more structured approach to data evaluation and thereby achieve increased transparency and predictability of the risk assessment process, and (3) to facilitate the use of non-guideline studies in regulatory risk assessment. 
 
Intended users of the evaluation criteria are risk assessors and researchers performing ecotoxicological experiments, but the criteria can also be used for education purposes and in the peer-review process for scientific papers.
 
This work was performed in collaboration between MistraPharma and the German Federal Environment Agency.

 
For more information, please contact Marlene Ågerstrand at maa2@kth.se.

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