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Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
Bennett CL, Schoen MW, Hoque S, Witherspoon BJ, Aboulafia DM, Hwang CS, Ray P, Yarnold PR, Chen BK, Schooley B, Taylor MA, Wyatt MD, Hrushesky WJ, Yang YT. Bennett CL, et al. Among authors: witherspoon bj. Lancet Oncol. 2020 Dec;21(12):e575-e588. doi: 10.1016/S1470-2045(20)30485-X. Lancet Oncol. 2020. PMID: 33271114 Review.
Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.
Chen B, Nagai S, Armitage JO, Witherspoon B, Nabhan C, Godwin AC, Yang YT, Kommalapati A, Tella SH, DeAngelis C, Raisch DW, Sartor O, Hrushesky WJ, Ray PS, Yarnold PR, Love BL, Norris LB, Knopf K, Bobolts L, Riente J, Luminari S, Kane RC, Hoque S, Bennett CL. Chen B, et al. Oncologist. 2019 Apr;24(4):537-548. doi: 10.1634/theoncologist.2018-0341. Epub 2019 Mar 6. Oncologist. 2019. PMID: 30842244 Free PMC article.
Caveat Medicus: Clinician experiences in publishing reports of serious oncology-associated adverse drug reactions.
Bennett CL, Schooley B, Taylor MA, Witherspoon BJ, Godwin A, Vemula J, Ausdenmoore HC, Sartor O, Yang YT, Armitage JO, Hrushesky WJ, Restaino J, Thomsen HS, Yarnold PR, Young T, Knopf KB, Chen B. Bennett CL, et al. Among authors: witherspoon bj. PLoS One. 2019 Jul 31;14(7):e0219521. doi: 10.1371/journal.pone.0219521. eCollection 2019. PLoS One. 2019. PMID: 31365527 Free PMC article.
An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin-association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency.
Bennett AC, Bennett CL, Witherspoon BJ, Knopf KB. Bennett AC, et al. Among authors: witherspoon bj. Expert Opin Drug Saf. 2019 Nov;18(11):1055-1063. doi: 10.1080/14740338.2019.1665022. Epub 2019 Sep 18. Expert Opin Drug Saf. 2019. PMID: 31500468 Free PMC article. Review.
End of an era for erythropoiesis-stimulating agents in oncology.
Schoen MW, Hoque S, Witherspoon BJ, Schooley B, Sartor O, Yang YT, Yarnold PR, Knopf KB, Hrushesky WJM, Dickson M, Chen BJ, Nabhan C, Bennett CL. Schoen MW, et al. Among authors: witherspoon bj. Int J Cancer. 2020 May 15;146(10):2829-2835. doi: 10.1002/ijc.32917. Epub 2020 Feb 28. Int J Cancer. 2020. PMID: 32037527 Free article.
Response to: letter to the editor: consideration on 'an evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the food and drug administration and the European medicines agency' by bennett et al.
Bennett AC, Bennett CL, Witherspoon BJ. Bennett AC, et al. Among authors: witherspoon bj. Expert Opin Drug Saf. 2020 Aug;19(8):1057-1058. doi: 10.1080/14740338.2020.1763691. Expert Opin Drug Saf. 2020. PMID: 32364807 Free PMC article.
End of an era of administering erythropoiesis stimulating agents among Veterans Administration cancer patients with chemotherapy-induced anemia.
Hoque S, Chen BJ, Schoen MW, Carson KR, Keller J, Witherspoon BJ, Knopf KB, Yang YT, Schooley B, Nabhan C, Sartor O, Yarnold PR, Ray P, Bobolts L, Hrushesky WJ, Dickson M, Bennett CL. Hoque S, et al. Among authors: witherspoon bj. PLoS One. 2020 Jun 25;15(6):e0234541. doi: 10.1371/journal.pone.0234541. eCollection 2020. PLoS One. 2020. PMID: 32584835 Free PMC article.
Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997-2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR).
Bennett CL, Hoque S, Olivieri N, Taylor MA, Aboulafia D, Lubaczewski C, Bennett AC, Vemula J, Schooley B, Witherspoon BJ, Godwin AC, Ray PS, Yarnold PR, Ausdenmoore HC, Fishman M, Herring G, Ventrone A, Aldaco J, Hrushesky WJ, Restaino J, Thomsen HS, Yarnold PR, Marx R, Migliorati C, Ruggiero S, Nabhan C, Carson KR, McKoy JM, Yang YT, Schoen MW, Knopf K, Martin L, Sartor O, Rosen S, Smith WK. Bennett CL, et al. Among authors: witherspoon bj. EClinicalMedicine. 2020 Dec 23;31:100693. doi: 10.1016/j.eclinm.2020.100693. eCollection 2021 Jan. EClinicalMedicine. 2020. PMID: 33554084 Free PMC article.
13 results