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  • Veröffentlichung
    Nanopharmaceuticals - tiny challenges for the environmental risk assessment of pharmaceuticals
    (2015) Berkner, Silvia; Schwirn, Kathrin; Völker, Doris
    Many new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think; indeed, nanopharmaceuticals have been marketed for many years, and the future is likely to bring more nanosized compounds to the market. Therefore, it is time to examine whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate, and effects of nanopharmaceuticals in an adequate way. Challenges include the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. Environ Toxicol Chem 2015;9999:1-8. © 2015 The Authors. Environmental Toxicology & Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.
  • Veröffentlichung
    Results of extended plant tests using more realistic exposure scenarios for improving environmental risk assessment of veterinary pharmaceuticals
    (2016) Richter, Elisabeth; Berkner, Silvia; Ebert, Ina; Förster, Bernhard; Graf, Nadine; Herrchen, Monika; Kühnen, Ute; Römbke, Jörg; Simon, Markus
  • Veröffentlichung
    Validation of a method to determine transformation of chemicals in anaerobic liquid pig and cattle manure for the OECD test guideline programme
    (2022) Berkner, Silvia; Anke, Julia Margaretha; Düring, Rolf-Alexander; Walter-Rohde, Susanne
    Manure is widely used as a fertilizer and applied to agricultural land. It may contain highly active chemicals like veterinary medicinal products or biocides, which enter into the environment by this pathway. This is recognized by several regulatory frameworks, however, a detailed method for examining the transformation of chemicals in manure was lacking. This article describes the validation of a method for studying the anaerobic transformation of chemicals in pig and cattle liquid manure. Different steps are covered with an emphasis on the validation ring test and the OECD (Organisation for Economic Cooperation and Development) process that led to the recent adoption of the method as OECD Test Guideline (TG) 320. © 2022 The Authors.