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BSTP Review of 12 Case Studies Discussing the Challenges, Pathology, Immunogenicity, and Mechanisms of Inhaled Biologics.
Hall AP, Tepper JS, Boyle MH, Cary MG, Flandre TG, Piaia A, Tarnow I, Macri NP, Freke MC, Nikula KJ, Paul GR, Cauvin A, Gregori M, Haworth R, Naylor S, Price M, Robinson IN, Allen A, Gelzleichter T, Hohlbaum AM, Manetz S, Wolfreys A, Colman K, Fleurance R, Jones D, Mukaratirwa S. Hall AP, et al. Among authors: fleurance r. Toxicol Pathol. 2021 Feb;49(2):235-260. doi: 10.1177/0192623320976094. Epub 2021 Jan 18. Toxicol Pathol. 2021. PMID: 33455525 Review.
Scientific and Regulatory Policy Committee Points to Consider: Histopathologic Evaluation in Safety Assessment Studies for PEGylated Pharmaceutical Products.
Irizarry Rovira AR, Bennet BM, Bolon B, Braendli-Baiocco A, Chandra S, Fleurance R, Garman R, Hutto D, Lane J, Romeike A, Sargeant A, Zimmerman B. Irizarry Rovira AR, et al. Among authors: fleurance r. Toxicol Pathol. 2018 Aug;46(6):616-635. doi: 10.1177/0192623318791801. Epub 2018 Aug 9. Toxicol Pathol. 2018. PMID: 30092727 Review.
Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules - A survey of industry 2008-2019.
MacLachlan TK, Price S, Cavagnaro J, Andrews L, Blanset D, Cosenza ME, Dempster M, Galbreath E, Giusti AM, Heinz-Taheny KM, Fleurance R, Sutter E, Leach MW. MacLachlan TK, et al. Among authors: fleurance r. Regul Toxicol Pharmacol. 2021 Apr;121:104872. doi: 10.1016/j.yrtph.2021.104872. Epub 2021 Jan 22. Regul Toxicol Pharmacol. 2021. PMID: 33485926
Evaluating Associations Between Nonclinical Cardiovascular Functional Endpoints and Repeat-dose Cardiovascular Toxicity in the Beagle Dog: A Cross-company Initiative.
Milliken P, Aylott M, Edmunds N, Engle S, Ewart L, Fleurance R, Guffroy M, Hargreaves A, Heinz-Taheny K, Kirk S, Leishman D, Leong L, McMahon N, Valentin JP, Watson D, Wallis R, Clements P. Milliken P, et al. Among authors: fleurance r. Toxicol Sci. 2020 Jul 1;176(1):224-235. doi: 10.1093/toxsci/kfaa051. Toxicol Sci. 2020. PMID: 32298455
Discovery and Characterization of Potent, Efficacious, Orally Available Antimalarial Plasmepsin X Inhibitors and Preclinical Safety Assessment of UCB7362.
Lowe MA, Cardenas A, Valentin JP, Zhu Z, Abendroth J, Castro JL, Class R, Delaunois A, Fleurance R, Gerets H, Gryshkova V, King L, Lorimer DD, MacCoss M, Rowley JH, Rosseels ML, Royer L, Taylor RD, Wong M, Zaccheo O, Chavan VP, Ghule GA, Tapkir BK, Burrows JN, Duffey M, Rottmann M, Wittlin S, Angulo-Barturen I, Jiménez-Díaz MB, Striepen J, Fairhurst KJ, Yeo T, Fidock DA, Cowman AF, Favuzza P, Crespo-Fernandez B, Gamo FJ, Goldberg DE, Soldati-Favre D, Laleu B, de Haro T. Lowe MA, et al. Among authors: fleurance r. J Med Chem. 2022 Oct 27;65(20):14121-14143. doi: 10.1021/acs.jmedchem.2c01336. Epub 2022 Oct 10. J Med Chem. 2022. PMID: 36216349 Free PMC article.
Striatal changes underlie MPEP-mediated suppression of the acquisition and expression of pramipexole-induced place preference in an alpha-synuclein rat model of Parkinson's disease.
Loiodice S, McGhan P, Gryshkova V, Fleurance R, Dardou D, Hafidi A, Nogueira da Costa A, Durif F. Loiodice S, et al. Among authors: fleurance r. J Psychopharmacol. 2017 Oct;31(10):1323-1333. doi: 10.1177/0269881117714051. Epub 2017 Jun 20. J Psychopharmacol. 2017. PMID: 28631520
15 results