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Year Number of Results
2002 4
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2005 6
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2009 1
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2011 4
2012 4
2013 5
2014 3
2015 3
2016 5
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2024 3

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Page 1
Translation of nonclinical to clinical safety findings for 27 biotherapeutics.
Leach MW, Rana P, Hu W, Mittapalli RK, Pinkstaff J, Potter D, Qiu XM, Ramaiah L, Rohde C, Xia F, Khan KN. Leach MW, et al. Toxicol Appl Pharmacol. 2024 Mar;484:116854. doi: 10.1016/j.taap.2024.116854. Epub 2024 Feb 10. Toxicol Appl Pharmacol. 2024. PMID: 38346540 Free article.
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: leach mw. 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: leach mw. 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.
80 results