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The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.
Prior H, Andrews L, Cauvin A, Chien H, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Reid K, Schutte K, Sewell F, Trouba K, Ulrich P, van Aerts L, van Meer P, Weir L. Prior H, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2023 Feb;138:105339. doi: 10.1016/j.yrtph.2023.105339. Epub 2023 Jan 14. Regul Toxicol Pharmacol. 2023. PMID: 36649820 Free article. Review.
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.
Chien HT, Prior H, Andrews L, van Aerts L, Cauvin A, Clarke DO, Datta K, Dempster M, Dybdal N, Freebern W, de Haan L, Herzyk D, Hey A, Kissner T, Kronenberg S, Leach MW, Lee D, Schutte K, Sewell F, Trouba K, Ulrich P, Weir L, van Meer P. Chien HT, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2023 Feb;138:105329. doi: 10.1016/j.yrtph.2022.105329. Epub 2022 Dec 30. Regul Toxicol Pharmacol. 2023. PMID: 36592682 Free article.
Finding synergies for 3Rs - Toxicokinetics and read-across: Report from an EPAA partners' Forum.
Laroche C, Aggarwal M, Bender H, Benndorf P, Birk B, Crozier J, Dal Negro G, De Gaetano F, Desaintes C, Gardner I, Hubesch B, Irizar A, John D, Kumar V, Lostia A, Manou I, Monshouwer M, Müller BP, Paini A, Reid K, Rowan T, Sachana M, Schutte K, Stirling C, Taalman R, van Aerts L, Weissenhorn R, Sauer UG. Laroche C, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2018 Nov;99:5-21. doi: 10.1016/j.yrtph.2018.08.006. Epub 2018 Aug 23. Regul Toxicol Pharmacol. 2018. PMID: 30144470 Free article.
A comprehensive view on mechanistic approaches for cancer risk assessment of non-genotoxic agrochemicals.
Luijten M, Corvi R, Mehta J, Corvaro M, Delrue N, Felter S, Haas B, Hewitt NJ, Hilton G, Holmes T, Jacobs MN, Jacobs A, Lamplmair F, Lewis D, Madia F, Manou I, Melching-Kollmuss S, Schorsch F, Schütte K, Sewell F, Strupp C, van der Laan JW, Wolf DC, Wolterink G, Woutersen R, Zvonar Z, Heusinkveld H, Braakhuis H. Luijten M, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2020 Dec;118:104789. doi: 10.1016/j.yrtph.2020.104789. Epub 2020 Oct 7. Regul Toxicol Pharmacol. 2020. PMID: 33035627 Free article. Review.
One science-driven approach for the regulatory implementation of alternative methods: A multi-sector perspective.
Dal Negro G, Eskes C, Belz S, Bertein C, Chlebus M, Corvaro M, Corvi R, Dhalluin S, Halder M, Harvey J, Hermann M, Hoffmann-Dörr S, Kilian K, Lambrigts D, Laroche C, Louhimies S, Mahony C, Manou I, McNamee P, Prieto P, Reid K, Roggen E, Schutte K, Stirling C, Uhlrich S, Weissenhorn R, Whelan M. Dal Negro G, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2018 Nov;99:33-49. doi: 10.1016/j.yrtph.2018.08.002. Epub 2018 Aug 8. Regul Toxicol Pharmacol. 2018. PMID: 30098372 Free article.
Finding synergies for the 3Rs - Repeated Dose Toxicity testing: Report from an EPAA Partners' Forum.
Laroche C, Annys E, Bender H, Botelho D, Botham P, Brendler-Schwaab S, Clayton R, Corvaro M, Dal Negro G, Delannois F, Dent M, Desaintes C, Desprez B, Dhalluin S, Hartmann A, Hoffmann-Doerr S, Hubesch B, Irizar A, Manou I, Müller BP, Nadzialek S, Prieto P, Rasenberg M, Roggeband R, Rowan TG, Schutte K, van de Water B, Westmoreland C, Whelan M, Wilschut A, Zvonimir Z, Cronin MTD. Laroche C, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2019 Nov;108:104470. doi: 10.1016/j.yrtph.2019.104470. Epub 2019 Aug 31. Regul Toxicol Pharmacol. 2019. PMID: 31479718 Free article.
Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.
Schutte K, Szczepanska A, Halder M, Cussler K, Sauer UG, Stirling C, Uhlrich S, Wilk-Zasadna I, John D, Bopst M, Garbe J, Glansbeek HL, Levis R, Serreyn PJ, Smith D, Stickings P. Schutte K, et al. Biologicals. 2017 Jul;48:55-65. doi: 10.1016/j.biologicals.2017.05.006. Epub 2017 Jun 7. Biologicals. 2017. PMID: 28596049 Free article.
Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop.
Westmoreland C, Bender HJ, Doe JE, Jacobs MN, Kass GEN, Madia F, Mahony C, Manou I, Maxwell G, Prieto P, Roggeband R, Sobanski T, Schütte K, Worth AP, Zvonar Z, Cronin MTD. Westmoreland C, et al. Among authors: schutte k. Regul Toxicol Pharmacol. 2022 Nov;135:105261. doi: 10.1016/j.yrtph.2022.105261. Epub 2022 Sep 11. Regul Toxicol Pharmacol. 2022. PMID: 36103951 Free article.
Towards a 21st-century roadmap for biomedical research and drug discovery: consensus report and recommendations.
Langley GR, Adcock IM, Busquet F, Crofton KM, Csernok E, Giese C, Heinonen T, Herrmann K, Hofmann-Apitius M, Landesmann B, Marshall LJ, McIvor E, Muotri AR, Noor F, Schutte K, Seidle T, van de Stolpe A, Van Esch H, Willett C, Woszczek G. Langley GR, et al. Among authors: schutte k. Drug Discov Today. 2017 Feb;22(2):327-339. doi: 10.1016/j.drudis.2016.10.011. Epub 2016 Oct 29. Drug Discov Today. 2017. PMID: 27989722 Free article. Review.
219 results