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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: kronenberg s. 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.
New challenges and opportunities in nonclinical safety testing of biologics.
Baumann A, Flagella K, Forster R, de Haan L, Kronenberg S, Locher M, Richter WF, Theil FP, Todd M. Baumann A, et al. Among authors: kronenberg s. Regul Toxicol Pharmacol. 2014 Jul;69(2):226-33. doi: 10.1016/j.yrtph.2014.04.005. Epub 2014 Apr 19. Regul Toxicol Pharmacol. 2014. PMID: 24755365
Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing.
Ulrich P, Blaich G, Baumann A, Fagg R, Hey A, Kiessling A, Kronenberg S, Lindecrona RH, Mohl S, Richter WF, Tibbitts J, Crameri F, Weir L. Ulrich P, et al. Among authors: kronenberg s. Regul Toxicol Pharmacol. 2018 Apr;94:91-100. doi: 10.1016/j.yrtph.2018.01.013. Epub 2018 Jan 28. Regul Toxicol Pharmacol. 2018. PMID: 29355662
Nonclinical Development of Biologics: Integrating Safety, Pharmacokinetics, and Pharmacodynamics to Create Smarter and More Flexible Nonclinical Safety Programs Optimizing Animal Use.
Hey A, Baumann A, Kronenberg S, Blaich G, Mohl S, Fagg R, Ulrich P, Rattel B, Richter WF, Kiessling A, Weir L. Hey A, et al. Among authors: kronenberg s. Int J Toxicol. 2021 May-Jun;40(3):270-284. doi: 10.1177/1091581821994288. Epub 2021 Feb 25. Int J Toxicol. 2021. PMID: 33631988
54 results