Author:
Ågerstrand Marlene,Breitholtz Magnus,Rudén Christina
Abstract
Abstract
Background
Standard 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.
The aim of this study was to investigate if non-standard ecotoxicity data can be evaluated systematically in risk assessments of pharmaceuticals. This has been 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.
Results
The same test data were evaluated differently by the four methods in seven out of nine cases. The selected non-standard test data were considered reliable/acceptable in only 14 out of 36 cases.
Conclusions
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. Reliability evaluation criteria could be used as a checklist to ensure that all important aspects are reported and thereby increasing the possibility that the data could be used for regulatory risk assessment.
Publisher
Springer Science and Business Media LLC
Reference39 articles.
1. European Medicines Agency (EMA), Committee for medicinal products for human use (CHMP): Guideline on the environmental risk assessment of medicinal products for human use. 2006. Ref EMEA/CRMP/SWP/4447/00
2. OECD: OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. No. 1 OECD Principles of Good Laboratory Practice. Paris: Organization for Economic and Co-operative Development; 1998.
3. vom Saal F, Myers JP: Good Laboratory Practices Are Not Synonymous with Good Scientific Practices, Accurate Reporting, or Valid Data. Environmental Health Perspective, Perspectives Correspondence 2010,118(2):A60.
4. Myers JP, vom Saal FS, Akingbemi BT, Arizono K, Belcher S, Colborn T, Chahoud I, Crain DA, Farabollini F, Guillette LJ, Hassold T, Ho S, Hunt PA, Iguchi T, Jobling S, Kanno J, Laufer H, Marcus M, McLachlan JA, Nadal A, Oehlmann J, Olea N, Palanza P, Parmigiani S, Rubin BS, Schoenfelder G, Sonnenschein C, Soto AM, Talsness CE, Taylor JA, Vandenberg LN, Vandenbergh JG, Vogel S, Watson CS, Welshons WV, Zoeller RT: Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A. Environmental Health Perspective 2009, 117: 309–315.
5. Gunnarsson L, Jauhiainen A, Kristiansson E, Nerman O, Larsson DG: Evolutionary conservation of human drug targets in organisms used for environmental risk assessments. Environmental Science and Technology 2008,42(15):5807–5813. 10.1021/es8005173
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