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Veröffentlichung Antibiotic resistance and the environment̶there and back again(2014) Berkner, Silvia; Konradi, Sabine; Schönfeld, JensVeröffentlichung Nanopharmaceuticals - tiny challenges for the environmental risk assessment of pharmaceuticals(2015) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisMany 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, MarkusVeröffentlichung Development of a test method for transformation of veterinary pharmaceuticals and biocides in anaerobic liquid manure(2020) Junker, Thomas; Atorf, Cornelia; Berkner, Silvia; Konradi, SabineBackground Spreading of manure on agricultural soils represents an important pathway by which veterinary medicinal and biocidal products enter the environment. To assess their environmental impact in the context of authorization processes, experimental testing of transformation of these compounds in manure is considered in regulatory guidance documents. However, there is no standardized experimental test method available so far. To fill this gap, an experimental test method was developed to examine transformation in liquid cattle and pig manure. Results To account for manure specifics and for a possible influence of manure parameters on transformation rates, a comprehensive data acquisition and statistical analysis were performed. To address the variability of liquid manure of different type and origin, 30 manures were sampled and characterized. Thereof, three cattle and three pig manures were selected to perform anaerobic transformation studies with two radiolabeled veterinary medicinal active substances (14C-salicylic acid and 14C-paracetamol) and a confidential radiolabeled "14C-biocide B" serving as test compounds. Spatial and seasonal variability of manure parameters was quantified, and a sampling technique to obtain homogenous manure samples was developed. Transformation studies with six replicates per sampling point were conducted to examine the influence of test setup, of manure storage conditions, and of parameter variations between manure of the same species and of different species on half-lives, formation of extractable and non-extractable residues and mineralization rates. Finally, a test design was established that yields reproducible results for transformation studies in liquid cattle and pig manure under anaerobic conditions. Conclusions Results give a reliable basis for an experimental test method to perform anaerobic transformation studies in liquid cattle and pig manure. The developed test method comprises detailed guidance on selection of sampling date and site, collection from manure tank, storage duration and temperature in the laboratory, duration of manure acclimation period, and the incubation system design. It proved to give reproducible results in a validation ring test performed in a follow-up project and is planned to be submitted as draft test guideline for approval by the OECD. © The Author(s) 2020.Veröffentlichung Too advanced for assessment? Advanced materials, nanomedicine and the environment(2022) Berkner, Silvia; Schwirn, Kathrin; Völker, DorisAdvanced materials, and nanomaterials, are promising for healthcare applications and are in particular in the spotlight of medical innovation since rapidly developed nano-formulated vaccines provide relief in the SARS-CoV-2 pandemic. Further increased rapid growth is to be expected as more and more products are in development and reach the market, beneficial for human health. However, the human body is not a dead end and these products are likely to enter the environment, whereas their fate and effects in the environment are unknown. This part of the life-cycle of advanced medicinal products tends to be overlooked, if the perspective is human-centered and excludes the connectedness of human activity with, and consequences for our environment. Gaps are reviewed that exist in awareness, perspective taking, inclusion of environmental concerns into research and product development and also in available methodologies and regulatory guidance. To bridge these gaps, possible ways forward start to emerge, that could help to find a more integrative way of assessing human and environmental safety for advanced material medicinal products and nanomedicines. © The Author(s) 2022.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, SusanneManure 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.Veröffentlichung Comparing pharmaceutical persistence across terrestrial and aquatic environments: do studies according to OECD 307 and OECD 308 lead to similar outcomes?(2023) Berkner, Silvia; Brandt, UteInformation on transformation and persistence of chemical substances in the environment is important for hazard and risk assessment within a regulatory context or as a decision criterion in a safe and sustainable by design framework. Half-lives for human and veterinary medicinal products available from marketing authorization applications were compared between soil (OECD 307) and aquatic water/sediment systems (OECD 308). The comparison shows, that there is no obvious correlation between the total system half-lives in the two different compartments and that surpassing persistence criteria is compartment-specific in 45% of the cases. © The Author(s) 2023