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Leistungen
This report describes the selection process of approximately 15 APIs that will be tested in WP1.3 because of a lack of data to conclude on the potential for environmental risk. This includes a description of the original API list considered, the decision tree(s) used for prioritisation, the prioritisation results, the criteria used for API selection, and the ultimate results of the selection process.
Determine bioavailability, metabolism and biological effects of MPA in fish (D2.2.5) (öffnet in neuem Fenster)Uptake will be measured using rainbow trout gill cell assay; bioavailability will be quantified via blood plasma protein binding measurements in trout and fathead minnow; metabolism will be measured using trout hepatocyte assay; developmental toxicity will be measured using the ZEDTA assay; immunotoxicity will be measured using transgenic zebrafish to track B and T cells, neutrophils and macrophages.
Report on stakeholder questions and requirements and work plan for further guidance development (D4.1.1) (öffnet in neuem Fenster)Report on the stakeholder questions and requirements, as identified during interviews and web-based questionnaire, the results of the workshop, the identified possible guidance products and the work plan for further guidance development.
A report describing the feasibility of greener drug design (D4.2.4) (öffnet in neuem Fenster)Consensus document that determines whether greener drug design is feasible and how it can be realised if the potential exists.
Report summarising drug discovery and development process and key attributes of tools/models (D4.2.1) (öffnet in neuem Fenster)Report highlighting a clear understanding where environmental hazard and risk are currently considered in the drug development process and where future potential exists for earlier integration of these considerations together with the attributes required for environmental screening tools/ models.
Evaluation of fish gill uptake and hepatic clearance for 10-20 APIs, including feasibility of the OECD 319b test or organ-chips for prediction of in vivo hepatic clearance of APIs in fish (D2.3.1) (öffnet in neuem Fenster)Assessment of the API uptake (bioavailability) and clearance of selected APIs in a primary 3D rainbow trout gill cell culture assay system and an analyses on the hepatic clearance of selected APIs through the use of (i) a primary 3D rainbow trout liver cell culture assay and (ii) a rainbow trout subcellular S9 fraction.
List of approximately 10 APIs selected for MoA-driven testing in WP1.3 (D1.1.2) (öffnet in neuem Fenster)This report describes the selection process of approximately 10 APIs that will be tested in WP1.3 because of a lack of ecotoxicity data on their specific Mode of Action. This includes a description of how the universe of APIs was compiled, the decision tree(s), the prioritisation results, the criteria used for API selection and the final results.
Mechanistic understanding on the potential for targeted pharmacological responses to mediate chronic effect outcomes from the application of transgenic zebrafish models (D2.3.3) (öffnet in neuem Fenster)Physiological/functional outcomes for selected APIs with specific pharmacological target activation prioritised in WP2.2 will be investigated using transgenic reporter zebrafish. The resulting data will be made available for use in the iterative assessment in WP1.2.
Project communication plan and initial toolset (öffnet in neuem Fenster)A plan for dissemination that includes the communication objectives, target audiences, activities to be carried out and tools that will support their implementation, with connections among these components. It will also include an initial set of communication materials.
Initial Data and Knowledge Management plan (D3.3.2) (öffnet in neuem Fenster)Outline for the PREMIER data and knowledge management policy.
Guidance for first set of selected stakeholder questions and requirements (D4.1.2) (öffnet in neuem Fenster)A first guidance document based on the main priorities identified in D4.1.1.
Machine-learning based models for estimating sorption in sludge, sediment, soil and sorbents used in treatment (D2.1.2) (öffnet in neuem Fenster)Report describing the generalized model for estimating sorption behaviour in sludge, soil, sediment and sorbents used in treatment processes.
Evaluation of the risk for bio-accumulation of APIs in fish via irreversible inhibition of hepatic CYPs (D2.3.2) (öffnet in neuem Fenster)The ability of selected APIs to irreversibly inhibit CYP enzyme activity will be quantified (IC50 shift) using rainbow trout RT-S9 and well-plate technologies.
Summary report describing fundamental drug design principles and their environmental significance (D4.2.2) (öffnet in neuem Fenster)onsensus document that describes industry-wide principles used to design safe and efficacious medicines.
All known APIs in use in Europe have been entered into the PREMIER database in collaboration with WP3.1. Additionally, data on name(s), CAS-No, IUPAC International Chemical Identifier (InChI), ATC classification, therapeutic plasma concentration, defined daily doses, usage, therapeutic MoA, physico-chemical properties and ecotoxicity, as far as available at this point in time, have been added to the PREMIER database.
PREMIER ERA database architecture agreed and established (D3.1.1) (öffnet in neuem Fenster)An initial structure of the database will be agreed between partners to capture APIs authorised for use in Europe and facilitate the upload of existing environmental data.
Integration of existing GLP study data from industry partners and EPAR data (D3.1.3) (öffnet in neuem Fenster)Existing GLP study data from industry partners and EPAR data from the EMA website will be uploaded using agreed templates and used to populate the PREMIER database. The templates will be designed specifically for each study so that they enable summary reports to be generated that meet the need of the wider stakeholder community.
Veröffentlichungen
Autoren:
Caroline T. A. Moermond, Neele Puhlmann, A. Ross Brown, Stewart F. Owen, Jim Ryan, Jason Snape, Bastiaan J. Venhuis, and Klaus Kümmerer
Veröffentlicht in:
Environmental Science and Technology Letters, Ausgabe 23288930, 2022, ISSN 2328-8930
Herausgeber:
ACS (American Chemical Society) Publications
DOI:
10.1021/acs.estlett.2c00446
Autoren:
F.D. Spilsbury, P.A. Inostroza, P. Svedberg, C. Cannata, A.M.J. Ragas, T. Backhaus
Veröffentlicht in:
Water Research, 2023, Seite(n) 121002, ISSN 0043-1354
Herausgeber:
Elsevier BV
DOI:
10.1016/j.watres.2023.121002
Autoren:
Jasmin Hafner, Kathrin Fenner, and Andreas Scheidegger
Veröffentlicht in:
Environmental Science & Technology Letters, 2023, ISSN 0000-0000
Herausgeber:
Environmental Science & Technology Letters
DOI:
10.1021/acs.estlett.3c00526
Autoren:
Tea Pihlaja, Timo Oksanen, Netta Vinkvist, Tiina Sikanen
Veröffentlicht in:
Frontiers in Toxicology, Ausgabe 6, 2024, ISSN 2673-3080
Herausgeber:
Frontiers in Toxicology
DOI:
10.3389/ftox.2024.1406942
Autoren:
Cristiana Cannata, Thomas Backhaus, Irene Bramke, Maria Caraman, Anna Lombardo, Rhys Whomsley, Caroline T.A. Moermond, Ad M.J. Ragas
Veröffentlicht in:
Environment International, Ausgabe 183, 2024, Seite(n) 108379, ISSN 0160-4120
Herausgeber:
Pergamon Press Ltd.
DOI:
10.1016/j.envint.2023.108379
Autoren:
Leo Trostel, Claudia Coll, Kathrin Fenner, and Jasmin Hafner
Veröffentlicht in:
Environmental Science: Processes & Impacts, 2023, ISSN 0000-0000
Herausgeber:
Environmental Science: Processes & Impacts
DOI:
10.1039/d3em00161j
Autoren:
Rodrigo Vidaurre, Irene Bramke, Neele Puhlmann, Stewart F. Owen, Daniela Angst, Caroline Moermond, Bastiaan Venhuis, Anna Lombardo, Klaus Kümmerer, Tiina Sikanen, Jim Ryan, Andreas Häner, Gemma Janer, Silvio Roggo, Alison Nimrod Perkins
Veröffentlicht in:
Drug Discovery Today, Ausgabe 29, 2024, Seite(n) 104022, ISSN 1359-6446
Herausgeber:
Elsevier BV
DOI:
10.1016/j.drudis.2024.104022
Autoren:
Anja Coors, A. Ross Brown, Samual K Maynard, Alison Nimrod Perkins, Stewart Owen, Charles R Tyler
Veröffentlicht in:
ACS publications, 2023, ISSN 0000-0000
Herausgeber:
American Chemical Society
DOI:
10.1021/acs.est.2c07222
Autoren:
Neele Puhlmann, Rodrigo Vidaurre, Klaus Kümmerer
Veröffentlicht in:
European Journal of Pharmaceutical Sciences, Ausgabe Volume 192, 1 January 2024, 106614, 2023, ISSN 0928-0987
Herausgeber:
Elsevier BV
DOI:
10.1016/j.ejps.2023.106614
Autoren:
Jiaqi Wang, Tom M. Nolte, Stewart F. Owen, Rémy Beaudouin, A. Jan Hendriks, and Ad M.J. Ragas
Veröffentlicht in:
Environmental Science & Technology, Ausgabe 0013936X, 2022, ISSN 0013-936X
Herausgeber:
American Chemical Society
DOI:
10.1021/acs.est.1c08068
Autoren:
Erika Colombo, Edoardo Luca Viganò, Giuseppa Raitano, Anna Lombardo, Alberto Manganaro, Alessio Sommovigo, Emilio Benfenati
Veröffentlicht in:
Chemosphere, Ausgabe 358, 2024, Seite(n) 142232, ISSN 0045-6535
Herausgeber:
Pergamon Press Ltd.
DOI:
10.1016/j.chemosphere.2024.142232
Autoren:
Chrisna Matthee, Andrew Ross Brown, Anke Lange, and Charles R. Tyler
Veröffentlicht in:
Environmental Science & Technology, 2023
Herausgeber:
ACS Publications
DOI:
10.1021/acs.est.2c09576
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