Leistungen
This report describes the selection process of approximately 15 APIs that will be tested in WP13 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 trees used for prioritisation the prioritisation results the criteria used for API selection and the ultimate results of the selection process
Report on stakeholder questions and requirements and work plan for further guidance development (D4.1.1)Report on the stakeholder questions and requirements as identified during interviews and webbased questionnaire the results of the workshop the identified possible guidance products and the work plan for further guidance development
Report summarising drug discovery and development process and key attributes of tools/models (D4.2.1)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
List of approximately 10 APIs selected for MoA-driven testing in WP1.3 (D1.1.2)This report describes the selection process of approximately 10 APIs that will be tested in WP13 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 trees the prioritisation results the criteria used for API selection and the final results
Project communication plan and initial toolsetA 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)Outline for the PREMIER data and knowledge management policy.
Evaluation of the risk for bio-accumulation of APIs in fish via irreversible inhibition of hepatic CYPs (D2.3.2)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)onsensus document that describes industrywide 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)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)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:
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:
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:
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:
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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