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.
Highlights
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
This study is divided into two parts: (1) an evaluation of the usefulness of four methods for reliability evaluation of test data that have been proposed in the scientific literature, and (2) an investigation of whether recently published non-standard ecotoxicity studies from the open scientific literature fulfill these reliability criteria
The results section is divided into the following sections: hypothesis and endpoints (Table 3), protocol (Table 4), test substance (Table 5), test environment (Table 6), dosing system (Table 7), test species (Table 8), controls (Table 9), statistical design (Table 10), and biological effect (Table 11)
Summary
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. The EMA risk assessment has a PEC/PNEC (predicted environmental concentration/predicted no effect concentration) approach and is divided into two phases. Non-standard tests, on the other hand, are tests performed according to any other test method
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