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FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations.
Ackley D, Birkebak J, Blumel J, Bourcier T, de Zafra C, Goodwin A, Halpern W, Herzyk D, Kronenberg S, Mauthe R, Shenton J, Shuey D, Wange RL. Ackley D, et al. Among authors: kronenberg s. Regul Toxicol Pharmacol. 2023 Feb;138:105327. doi: 10.1016/j.yrtph.2022.105327. Epub 2022 Dec 28. Regul Toxicol Pharmacol. 2023. PMID: 36586472 Free article.
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
Current nonclinical approaches for immune assessments of immuno-oncology biotherapeutics.
Grimaldi C, Ibraghimov A, Kiessling A, Rattel B, Ji C, Fuller CL, Brennan FR, Regenass-Lechner F, Shenton J, Price KD, Piché MS, Steeves MA, Prell R, Dudal S, Kronenberg S, Freebern W, Blanset D. Grimaldi C, et al. Among authors: kronenberg s. Drug Discov Today. 2023 Feb;28(2):103440. doi: 10.1016/j.drudis.2022.103440. Epub 2022 Nov 12. Drug Discov Today. 2023. PMID: 36375739 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: kronenberg s. 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.
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.
55 results