Cover of report "Do new generations of active pharmaceuticals for human use require an adaption of the environmental risk assessment?"
Chemicals

Do new generations of active pharmaceuticals for human use require an adaption of the environmental risk assessment? - Part II: Case studies


In view of the advanced development of new specific active pharmaceutical ingredients, the question arises as to whether the established standard procedures for the environmental risk assessment in the context of marketing authorization are still sufficient to adequately cover relevant effects on environmental organisms. The focus of this project is on specific test strategies for substances from the group of oncologicals, cardiologicals and statins, as well as their experimental verification in case studies. Studies with aquatic plants in the Lemna sp. Growth Inhibition Test (⁠OECD⁠ 221), the zebrafish embryo toxicity test (OECD 236) amended with sublethal endpoints and the comet assay with environmentally relevant cell types are discussed as possible adaptations, although not all of them proved to be suitable.

Reihe
Texte | 21/2024
Seitenzahl
135
Erscheinungsjahr
Autor(en)
Elke Eilebrecht, Karsten Schlich, Kornelija Franzen, Bernd Göckener, Anja Coors, Mirco Weil
Sprache
Englisch
Forschungskennzahl
3718 65 420 2
Verlag
German Environment Agency
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3264 KB
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Schlagworte:
 environmental risk assessment  medicinal product for human use  pharmaceuticals  active pharmaceutical ingredient