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Page 1
Challenges for inhaled drug discovery and development: Induced alveolar macrophage responses.
Forbes B, O'Lone R, Allen PP, Cahn A, Clarke C, Collinge M, Dailey LA, Donnelly LE, Dybowski J, Hassall D, Hildebrand D, Jones R, Kilgour J, Klapwijk J, Maier CC, McGovern T, Nikula K, Parry JD, Reed MD, Robinson I, Tomlinson L, Wolfreys A. Forbes B, et al. Among authors: wolfreys a. Adv Drug Deliv Rev. 2014 May;71:15-33. doi: 10.1016/j.addr.2014.02.001. Epub 2014 Feb 13. Adv Drug Deliv Rev. 2014. PMID: 24530633 Free article.
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: wolfreys a. Toxicol Pathol. 2021 Feb;49(2):235-260. doi: 10.1177/0192623320976094. Epub 2021 Jan 18. Toxicol Pathol. 2021. PMID: 33455525 Review.
Review of the Technical, Toxicological, and PKPD Considerations for Conducting Inhalation Toxicity Studies on Biologic Pharmaceuticals-The Outcome of a Cross-Industry Working Group Survey.
Wolfreys A, Kilgour J, Allen AD, Dudal S, Freke M, Jones D, Karantabias G, Krantz C, Moore S, Mukaratirwa S, Price M, Tepper J, Cauvin A, Manetz S, Robinson I. Wolfreys A, et al. Toxicol Pathol. 2021 Feb;49(2):261-285. doi: 10.1177/0192623321988841. Epub 2021 Feb 3. Toxicol Pathol. 2021. PMID: 33535023 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. Among authors: wolfreys a. 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.
The use of emerging safety biomarkers in nonclinical and clinical safety assessment - The current and future state: An IQ DruSafe industry survey.
Zabka TS, Burkhardt J, Reagan WJ, Gautier JC, Glaab WE, Guffroy M, Harding J, Brees D, McDuffie E, Ramaiah L, Schultze AE, Smith JD, Wolfreys A, Dalmas DA. Zabka TS, et al. Among authors: wolfreys a. Regul Toxicol Pharmacol. 2021 Mar;120:104857. doi: 10.1016/j.yrtph.2020.104857. Epub 2020 Dec 31. Regul Toxicol Pharmacol. 2021. PMID: 33387566 Free article.
Justification for species selection for pharmaceutical toxicity studies.
Prior H, Haworth R, Labram B, Roberts R, Wolfreys A, Sewell F. Prior H, et al. Among authors: wolfreys a. Toxicol Res (Camb). 2020 Nov 24;9(6):758-770. doi: 10.1093/toxres/tfaa081. eCollection 2020 Dec. Toxicol Res (Camb). 2020. PMID: 33442468 Free PMC article.
Nonclinical cardiovascular safety evaluation of romosozumab, an inhibitor of sclerostin for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
Turk JR, Deaton AM, Yin J, Stolina M, Felx M, Boyd G, Bienvenu JG, Varela A, Guillot M, Holdsworth G, Wolfreys A, Dwyer D, Kumar SV, de Koning EM, Qu Y, Engwall M, Locher K, Ward LD, Glaus C, He YD, Boyce RW. Turk JR, et al. Among authors: wolfreys a. Regul Toxicol Pharmacol. 2020 Aug;115:104697. doi: 10.1016/j.yrtph.2020.104697. Epub 2020 Jun 23. Regul Toxicol Pharmacol. 2020. PMID: 32590049 Free article.
18 results