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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: clarke do. 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.
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. 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.
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.
Leach MW, Clarke DO, Dudal S, Han C, Li C, Yang Z, Brennan FR, Bailey WJ, Chen Y, Deslandes A, Loberg LI, Mayawala K, Rogge MC, Todd M, Chemuturi NV. Leach MW, et al. Among authors: clarke do. Clin Pharmacol Ther. 2021 Jun;109(6):1395-1415. doi: 10.1002/cpt.2009. Epub 2020 Nov 3. Clin Pharmacol Ther. 2021. PMID: 32757299
A review of the abuse potential assessment of atomoxetine: a nonstimulant medication for attention-deficit/hyperactivity disorder.
Upadhyaya HP, Desaiah D, Schuh KJ, Bymaster FP, Kallman MJ, Clarke DO, Durell TM, Trzepacz PT, Calligaro DO, Nisenbaum ES, Emmerson PJ, Schuh LM, Bickel WK, Allen AJ. Upadhyaya HP, et al. Among authors: clarke do. Psychopharmacology (Berl). 2013 Mar;226(2):189-200. doi: 10.1007/s00213-013-2986-z. Epub 2013 Feb 9. Psychopharmacology (Berl). 2013. PMID: 23397050 Free PMC 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: clarke do. 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.
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