CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.
Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .
Resultado final
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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)Outline for the PREMIER data and knowledge management policy.
Guidance for first set of selected stakeholder questions and requirements (D4.1.2) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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.
Publicaciones
Autores:
Caroline T. A. Moermond, Neele Puhlmann, A. Ross Brown, Stewart F. Owen, Jim Ryan, Jason Snape, Bastiaan J. Venhuis, and Klaus Kümmerer
Publicado en:
Environmental Science and Technology Letters, Edición 23288930, 2022, ISSN 2328-8930
Editor:
ACS (American Chemical Society) Publications
DOI:
10.1021/acs.estlett.2c00446
Autores:
F.D. Spilsbury, P.A. Inostroza, P. Svedberg, C. Cannata, A.M.J. Ragas, T. Backhaus
Publicado en:
Water Research, 2023, Página(s) 121002, ISSN 0043-1354
Editor:
Elsevier BV
DOI:
10.1016/j.watres.2023.121002
Autores:
Jasmin Hafner, Kathrin Fenner, and Andreas Scheidegger
Publicado en:
Environmental Science & Technology Letters, 2023, ISSN 0000-0000
Editor:
Environmental Science & Technology Letters
DOI:
10.1021/acs.estlett.3c00526
Autores:
Tea Pihlaja, Timo Oksanen, Netta Vinkvist, Tiina Sikanen
Publicado en:
Frontiers in Toxicology, Edición 6, 2024, ISSN 2673-3080
Editor:
Frontiers in Toxicology
DOI:
10.3389/ftox.2024.1406942
Autores:
Cristiana Cannata, Thomas Backhaus, Irene Bramke, Maria Caraman, Anna Lombardo, Rhys Whomsley, Caroline T.A. Moermond, Ad M.J. Ragas
Publicado en:
Environment International, Edición 183, 2024, Página(s) 108379, ISSN 0160-4120
Editor:
Pergamon Press Ltd.
DOI:
10.1016/j.envint.2023.108379
Autores:
Leo Trostel, Claudia Coll, Kathrin Fenner, and Jasmin Hafner
Publicado en:
Environmental Science: Processes & Impacts, 2023, ISSN 0000-0000
Editor:
Environmental Science: Processes & Impacts
DOI:
10.1039/d3em00161j
Autores:
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
Publicado en:
Drug Discovery Today, Edición 29, 2024, Página(s) 104022, ISSN 1359-6446
Editor:
Elsevier BV
DOI:
10.1016/j.drudis.2024.104022
Autores:
Anja Coors, A. Ross Brown, Samual K Maynard, Alison Nimrod Perkins, Stewart Owen, Charles R Tyler
Publicado en:
ACS publications, 2023, ISSN 0000-0000
Editor:
American Chemical Society
DOI:
10.1021/acs.est.2c07222
Autores:
Neele Puhlmann, Rodrigo Vidaurre, Klaus Kümmerer
Publicado en:
European Journal of Pharmaceutical Sciences, Edición Volume 192, 1 January 2024, 106614, 2023, ISSN 0928-0987
Editor:
Elsevier BV
DOI:
10.1016/j.ejps.2023.106614
Autores:
Jiaqi Wang, Tom M. Nolte, Stewart F. Owen, Rémy Beaudouin, A. Jan Hendriks, and Ad M.J. Ragas
Publicado en:
Environmental Science & Technology, Edición 0013936X, 2022, ISSN 0013-936X
Editor:
American Chemical Society
DOI:
10.1021/acs.est.1c08068
Autores:
Erika Colombo, Edoardo Luca Viganò, Giuseppa Raitano, Anna Lombardo, Alberto Manganaro, Alessio Sommovigo, Emilio Benfenati
Publicado en:
Chemosphere, Edición 358, 2024, Página(s) 142232, ISSN 0045-6535
Editor:
Pergamon Press Ltd.
DOI:
10.1016/j.chemosphere.2024.142232
Autores:
Chrisna Matthee, Andrew Ross Brown, Anke Lange, and Charles R. Tyler
Publicado en:
Environmental Science & Technology, 2023
Editor:
ACS Publications
DOI:
10.1021/acs.est.2c09576
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