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The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates.
Chapman KL, Andrews L, Bajramovic JJ, Baldrick P, Black LE, Bowman CJ, Buckley LA, Coney LA, Couch J, Maggie Dempster A, de Haan L, Jones K, Pullen N, de Boer AS, Sims J, Ian Ragan C. Chapman KL, et al. Regul Toxicol Pharmacol. 2012 Mar;62(2):347-54. doi: 10.1016/j.yrtph.2011.10.016. Epub 2011 Nov 6. Regul Toxicol Pharmacol. 2012. PMID: 22100994
Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials.
Sewell F, Chapman K, Baldrick P, Brewster D, Broadmeadow A, Brown P, Burns-Naas LA, Clarke J, Constan A, Couch J, Czupalla O, Danks A, DeGeorge J, de Haan L, Hettinger K, Hill M, Festag M, Jacobs A, Jacobson-Kram D, Kopytek S, Lorenz H, Moesgaard SG, Moore E, Pasanen M, Perry R, Ragan I, Robinson S, Schmitt PM, Short B, Lima BS, Smith D, Sparrow S, van Bekkum Y, Jones D. Sewell F, et al. Among authors: chapman k. Regul Toxicol Pharmacol. 2014 Oct;70(1):413-29. doi: 10.1016/j.yrtph.2014.07.018. Epub 2014 Jul 29. Regul Toxicol Pharmacol. 2014. PMID: 25078890 Free article.
The future of non-human primate use in mAb development.
Chapman KL, Pullen N, Andrews L, Ragan I. Chapman KL, et al. Drug Discov Today. 2010 Mar;15(5-6):235-42. doi: 10.1016/j.drudis.2010.01.002. Epub 2010 Jan 21. Drug Discov Today. 2010. PMID: 20096369 Review.
A global pharmaceutical company initiative: an evidence-based approach to define the upper limit of body weight loss in short term toxicity studies.
Chapman K, Sewell F, Allais L, Delongeas JL, Donald E, Festag M, Kervyn S, Ockert D, Nogues V, Palmer H, Popovic M, Roosen W, Schoenmakers A, Somers K, Stark C, Stei P, Robinson S. Chapman K, et al. Regul Toxicol Pharmacol. 2013 Oct;67(1):27-38. doi: 10.1016/j.yrtph.2013.04.003. Epub 2013 Apr 19. Regul Toxicol Pharmacol. 2013. PMID: 23602904 Free article.
1,984 results