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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: sewell f. 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. 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 global initiative to refine acute inhalation studies through the use of 'evident toxicity' as an endpoint: Towards adoption of the fixed concentration procedure.
Sewell F, Ragan I, Marczylo T, Anderson B, Braun A, Casey W, Dennison N, Griffiths D, Guest R, Holmes T, van Huygevoort T, Indans I, Kenny T, Kojima H, Lee K, Prieto P, Smith P, Smedley J, Stokes WS, Wnorowski G, Horgan G. Sewell F, et al. Regul Toxicol Pharmacol. 2015 Dec;73(3):770-9. doi: 10.1016/j.yrtph.2015.10.018. Epub 2015 Oct 23. Regul Toxicol Pharmacol. 2015. PMID: 26505531 Free article.
Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation.
Prior H, Baldrick P, Beken S, Booler H, Bower N, Brooker P, Brown P, Burlinson B, Burns-Naas LA, Casey W, Chapman M, Clarke D, de Haan L, Doehr O, Downes N, Flaherty M, Gellatly N, Moesgaard SG, Harris J, Holbrook M, Hui J, Jones D, Jones K, Kedar H, Mahl A, Manninen A, McGuire A, Mortimer-Cassen E, Peraza M, Pugsley MK, Richard J, Roberts R, Roosen W, Rothfuss A, Schoenmakers A, Sewell F, Weaver R, Weir L, Wolfreys A, Kimber I. Prior H, et al. Among authors: sewell f. Regul Toxicol Pharmacol. 2020 Jun;113:104624. doi: 10.1016/j.yrtph.2020.104624. Epub 2020 Feb 29. Regul Toxicol Pharmacol. 2020. PMID: 32126256 Free article.
Predicting the safety of medicines in pregnancy: A workshop report.
Clements JM, Hawkes RG, Jones D, Adjei A, Chambers T, Simon L, Stemplewski H, Berry N, Price S, Pirmohamed M, Piersma AH, Waxenecker G, Barrow P, Beekhuijzen MEW, Fowkes A, Prior H, Sewell F. Clements JM, et al. Among authors: sewell f. Reprod Toxicol. 2020 Apr;93:199-210. doi: 10.1016/j.reprotox.2020.02.011. Epub 2020 Feb 29. Reprod Toxicol. 2020. PMID: 32126282 Free article.
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