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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. Among authors: robinson s. 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.
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: robinson s. 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.
A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.
Robinson S, Delongeas JL, Donald E, Dreher D, Festag M, Kervyn S, Lampo A, Nahas K, Nogues V, Ockert D, Quinn K, Old S, Pickersgill N, Somers K, Stark C, Stei P, Waterson L, Chapman K. Robinson S, et al. Regul Toxicol Pharmacol. 2008 Apr;50(3):345-52. doi: 10.1016/j.yrtph.2007.11.009. Epub 2007 Dec 5. Regul Toxicol Pharmacol. 2008. PMID: 18295384
5,098 results