2026-04-20T21:43:26Zhttps://riubu.ubu.es/oai/request

oai:riubu.ubu.es:10259/98032024-12-19T01:05:23Zcom_10259_6168com_10259_5086com_10259_2604col_10259_6169

Hristozov, Danail d2241f32-4306-4498-984a-c2da18c41e3e 500 Badetti, Elena 47da84d5-6373-4127-89ad-965ad97a7a9e 500 Bigini, Paolo 695b5697-d657-46c9-a0a8-6891563f27a8 500 Brunelli, Andrea e8a397ed-1b34-4b90-ab7c-bae5511158cf 500 Dekkers, Susan f972535e-a1fb-4f26-b60f-5b9f907e9888 500 Diomede, Luisa 538732e4-4b45-4477-bcac-6c7457d7efcd 500 Doak, Shareen H. c832c521-8ebf-46c1-90b9-148d9936ce55 500 Fransman, Wouter 3385abc6-c0f3-417d-96d7-1fb4bc38e73e 500 Gajewicz-Skretna, Agnieszka 5034d54a-dc03-4806-b000-ab02e853a59e 500 Giubilato, Elisa 3191fe3f-231f-4694-bd4f-2ba33cbf9ad2 500 Gómez Cuadrado, Laura 9514b3a3-cf2c-47f7-8cbe-5a961c5653b5 600 Grafström, Roland 28e75f31-d02c-4dd7-8cff-07e5edef52da 500 Gutleb, Arno C. 0a53a69c-9326-4173-b29d-6bff80795894 500 Halappanavar, Sabina 5a320ba6-783b-4676-a4f1-88d492ce1356 500 Hischier, Roland fdb73578-1e7b-4f2c-95fb-aa73bbfc7cb6 500 Hunt, Neil 55492736-39c6-4914-8a7b-48352c484f8c 500 Katsumiti, Alberto dc878db3-2b49-4fed-b0fe-ccff474a61fe 500 Kermanizadeh, Ali 0cd824a5-a50b-42df-a0f4-0275673f79a9 500 Marcomini, Antonio 58511483-ed33-4d81-baae-efd36ace3e39 500 Moschini, Elisa c254ba78-4501-479b-847a-e4277e60d65e 500 Oomen, Agnes a89a11bd-88e2-4a45-b96e-937f05f5ae52 500 Pizzol, Lisa 36ef0f80-6706-4dc6-9960-4d7772f41632 500 Rumbo Lorenzo, Carlos 505 600 0000-0002-5038-0334 Schmid, Otmar 2ce6500f-180d-43bd-95fb-d412ceb55be7 500 Shandilya, Neeraj e38126ec-69c2-4aa9-b5b1-d2a585d0a4bc 500 Stone, Vicki 0a1e1b6a-6341-483f-8bb6-1bc3e551fdfe 500 Stoycheva, Stella fcb5077a-fafd-48a5-a7cc-3e6d722caf5f 500 Stoeger, Tobias e2e89c7f-92ed-4a21-813e-b4cdd70fcf49 500 Merino, Blanca Suarez df6b4751-6bc6-4d14-8222-17c62c702a77 500 Tran, Lang e681b9b2-857a-4c5d-8dbb-b59951f94675 500 Tsiliki, Georgia d1f592d7-b095-4e18-9878-fde5e2dac0ce 500 Vogel, Ulla Birgitte 430432bf-a294-411d-a183-6129970759fe 500 Wohlleben, Wendel 5af892af-cf23-4324-83ee-ee56b91ef3aa 500 Zabeo, Alex 355b8870-27c4-4269-8fdb-21dd9b3f781d 500 2024-12-18T10:14:08Z 2024-12-18T10:14:08Z 2024-07 2452-0748 http://hdl.handle.net/10259/9803 10.1016/j.impact.2024.100523 This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas. This work was supported by the European Union's Horizon 2020 Programme under grant agreements 952924 (SUNSHINE project), 953183 (HARMLESS project) and 953152 (DIAGONAL project), and by the European Union's Horizon Europe Programme under grant agreements 101092901 (POTENTIAL project) and 101137324 (SUNRISE project). application/pdf eng Elsevier NanoImpact. 2024, V. 35, p. 100523 https://doi.org/10.1016/j.impact.2024.100523 Attribution-NonCommercial-NoDerivatives 4.0 Internacional http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Next Generation Risk Assessment (NGRA) New Approach Methodologies (NAMs) Advanced materials Nanomaterials Regulatory readiness Grouping In vitro approaches In vitro-in vivo extrapolation (IVIVE) In silico approaches In chemico approaches Nanotecnología Química orgánica Química Nanotechnology Chemistry, Organic Chemistry Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion NanoImpact 35 100523 THUMBNAIL Hristozov-NanoImpact_2024.pdf.jpg Hristozov-NanoImpact_2024.pdf.jpg IM Thumbnail image/jpeg 4849 https://riubu.ubu.es/bitstream/10259/9803/4/Hristozov-NanoImpact_2024.pdf.jpg 1b6769fa03dd6427a8e15864df8880e9 MD5 4 LICENSE license.txt license.txt text/plain; charset=utf-8 1362 https://riubu.ubu.es/bitstream/10259/9803/3/license.txt 5d013bfa6e473ff0db22cd82a4d71a70 MD5 3 CC-LICENSE license_rdf license_rdf application/rdf+xml; charset=utf-8 805 https://riubu.ubu.es/bitstream/10259/9803/2/license_rdf 4460e5956bc1d1639be9ae6146a50347 MD5 2 ORIGINAL Hristozov-NanoImpact_2024.pdf Hristozov-NanoImpact_2024.pdf application/pdf 3185284 https://riubu.ubu.es/bitstream/10259/9803/1/Hristozov-NanoImpact_2024.pdf 327e2e7cd701487cba205a0c76e94bc9 MD5 1 10259/9803 oai:riubu.ubu.es:10259/9803 2024-12-19 02:05:23.062 Repositorio Institucional de la Universidad de Burgos bubrep@ubu.es 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