Zobrazeno 1 - 10
of 14
pro vyhledávání: '"Bartlett J. Witherspoon"'
Autor:
Charles L. Bennett, Nancy Olivieri, Shamia Hoque, David Aboulafia, Anne Ventrone, Courtney Lubaczewski, Betty Dong, Benjamin Schooley, Bartlett J. Witherspoon, Paul S. Ray, William J. Hrushesky, John Restaino, Henrik S. Thomsen, Dennis Mangano, Christina Mora-Mangano, June M. McKoy, Martin Schoen, Kevin Knopf, Linda Martin, Steven Rosen
Publikováno v:
The Journal of Scientific Practice and Integrity (2022)
# Background We previously described experiences of clinicians who published adverse drug reaction reports. We now report on threats and intimidations leveled against clinicians and scientists who received publicly documented threats after communica
Externí odkaz:
https://doaj.org/article/c58a1f473a3e44cfa3fb8a9e0941656a
Autor:
Charles L. Bennett, Shamia Hoque, Nancy Olivieri, Matthew A. Taylor, David Aboulafia, Courtney Lubaczewski, Andrew C. Bennett, Jay Vemula, Benjamin Schooley, Bartlett J. Witherspoon, Ashley C Godwin, Paul S. Ray, Paul R. Yarnold, Henry C. Ausdenmoore, Marc Fishman, Georgne Herring, Anne Ventrone, Juan Aldaco, William J. Hrushesky, John Restaino, Henrik S. Thomsen, Robert Marx, Cesar Migliorati, Salvatore Ruggiero, Chadi Nabhan, Kenneth R. Carson, June M. McKoy, Y. Tony Yang, Martin W. Schoen, Kevin Knopf, Linda Martin, Oliver Sartor, Steven Rosen, William K. Smith
Publikováno v:
EClinicalMedicine, Vol 31, Iss , Pp 100693- (2021)
Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drug
Externí odkaz:
https://doaj.org/article/7660e72814e34fe8aaa2b0680f081e61
Autor:
David M. Aboulafia, Bartlett J. Witherspoon, Shamia Hoque, Michael D. Wyatt, Y. Tony Yang, Paul R. Yarnold, William J. M. Hrushesky, Catherine S Hwang, Brian Chen, Paul Ray, Martin W. Schoen, Charles L. Bennett, Matthew A. Taylor, Benjamin Schooley
Publikováno v:
The Lancet Oncology. 21:e575-e588
The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological dr
Autor:
Shamia Hoque, Michael Dickson, Paul R. Yarnold, Oliver Sartor, Bartlett J. Witherspoon, Benjamin Schooley, Chadi Nabhan, Charles L. Bennett, Brian J. Chen, William J. M. Hrushesky, Y. Tony Yang, Martin W. Schoen, Kevin B. Knopf
Publikováno v:
International Journal of Cancer. 146:2829-2835
Erythropoiesis-stimulating agents (ESAs) are available to treat chemotherapy-induced anemia (CIA). In 2007-2008, regulatory notifications advised of venous thromboembolism and mortality risks while the Center for Medicare and Medicaid Services' restr
Autor:
James O. Armitage, Shamia Hoque, Laura Rose Bobolts, LeAnn B. Norris, Sumimasa Nagai, Chadi Nabhan, Oliver Sartor, Anuhya Kommalapati, Robert C. Kane, Carlo DeAngelis, Paul R. Yarnold, Charles L. Bennett, Joshua Riente, Dennis W. Raisch, Brian Chen, Paul Ray, Ashley Caitlin Godwin, Stefano Luminari, William J. M. Hrushesky, Bryan L. Love, Bartlett J. Witherspoon, Kevin B. Knopf, Y. Tony Yang, Sri Harsha Tella
Publikováno v:
The Oncologist. 24:537-548
Biosimilar filgrastims are primarily indicated for chemotherapy-induced neutropenia prevention. They are less expensive formulations of branded filgrastim, and biosimilar filgrastim was the first biosimilar oncology drug administered in European Unio
Autor:
Shamia Hoque, Kevin B. Knopf, Marc L. Fishman, Steven D. Rosen, Courtney Lubaczewski, Paul Ray, Paul R. Yarnold, Oliver Sartor, Henry C. Ausdenmoore, Matthew A. Taylor, Robert E. Marx, Benjamin Schooley, Martin W. Schoen, Y. Tony Yang, Nancy F. Olivieri, David M. Aboulafia, Jay Vemula, William J. M. Hrushesky, Juan Aldaco, Salvatore L. Ruggiero, John Restaino, Henrik S. Thomsen, Anne Ventrone, Linda Martin, June M. McKoy, William K. Smith, Georgne Herring, Ashley Caitlin Godwin, Cesar A. Migliorati, Chadi Nabhan, Charles L. Bennett, Andrew C Bennett, Bartlett J. Witherspoon, Kenneth R. Carson
Publikováno v:
EClinicalMedicine
Bennett, C L, Hoque, S, Olivieri, N, Taylor, M A, Aboulafia, D, Lubaczewski, C, Bennett, A C, Vemula, J, Schooley, B, Witherspoon, B J, Godwin, A C, Ray, P S, Yarnold, P R, Ausdenmoore, H C, Fishman, M, Herring, G, Ventrone, A, Aldaco, J, Hrushesky, W J, Restaino, J, Thomsen, H S, Marx, R, Migliorati, C, Ruggiero, S, Nabhan, C, Carson, K R, McKoy, J M, Yang, Y T, Schoen, M W, Knopf, K, Martin, L, Sartor, O, Rosen, S & Smith, W K 2021, ' 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) ', EClinicalMedicine, vol. 31, 100693 . https://doi.org/10.1016/j.eclinm.2020.100693
EClinicalMedicine, Vol 31, Iss, Pp 100693-(2021)
Bennett, C L, Hoque, S, Olivieri, N, Taylor, M A, Aboulafia, D, Lubaczewski, C, Bennett, A C, Vemula, J, Schooley, B, Witherspoon, B J, Godwin, A C, Ray, P S, Yarnold, P R, Ausdenmoore, H C, Fishman, M, Herring, G, Ventrone, A, Aldaco, J, Hrushesky, W J, Restaino, J, Thomsen, H S, Marx, R, Migliorati, C, Ruggiero, S, Nabhan, C, Carson, K R, McKoy, J M, Yang, Y T, Schoen, M W, Knopf, K, Martin, L, Sartor, O, Rosen, S & Smith, W K 2021, ' 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) ', EClinicalMedicine, vol. 31, 100693 . https://doi.org/10.1016/j.eclinm.2020.100693
EClinicalMedicine, Vol 31, Iss, Pp 100693-(2021)
Background: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drug
Publikováno v:
Expert Opin Drug Saf
Pulmonary fibrosis includes several lung disorders characterized by progressive fibrosis, of which idiopathic pulmonary fibrosis (IPF) is a particularly severe form with a median survival time of 3...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f68c03a62ae9c2b58f640bf1b0687151
https://europepmc.org/articles/PMC9547382/
https://europepmc.org/articles/PMC9547382/
Autor:
Laura Rose Bobolts, Benjamin Schooley, Bartlett J. Witherspoon, Jesse Keller, Paul R. Yarnold, Brian J. Chen, Michael Dickson, Chadi Nabhan, Kenneth R. Carson, Martin W. Schoen, Kevin B. Knopf, Shamia Hoque, Y. Tony Yang, Oliver Sartor, William J. M. Hrushesky, Paul Ray, Charles L. Bennett
Publikováno v:
PLoS ONE
PLoS ONE, Vol 15, Iss 6, p e0234541 (2020)
PLoS ONE, Vol 15, Iss 6, p e0234541 (2020)
Erythropoisis stimulating agent (ESA) use was addressed in Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings between 2004 and 2008. FDA safety-focused regulatory actions occurred in 2007 and 2008. In 2007, black box
Autor:
Matthew A. Taylor, Kenneth R. Carson, Benjamin Schooley, Jay Vemula, Cesar A. Migliorati, Anne Ventrone, Martin Schooley, Henry C. Ausdenmoore, Shamia Hoque, William K. Smith, Courtney Lubaczewski, Andrew C. Bennett, Oliver Sartor, Paul Ray, Bartlett J. Witherspoon, Ashley Caitlin Godwin, Chadi Nabhan, Georgine Herring, Salvatore L. Ruggiero, Linda Martin, William J. M. Hrushesky, Charles L. Bennett, Steven D. Rosen, David M. Aboulafia, Henrik S. Thomsen, Paul R. Yarnold, June M. McKoy, Kevin B. Knopf, Robert E. Marx, Y. Tony Yang, John Restaino
Publikováno v:
SSRN Electronic Journal.
Introduction: Adverse drug/device reactions (ADRs) can result in severe patient harm. We operationally define titanic ADRs as Common Toxicity Criteria Adverse Events grade 4 or 5 that follow use of drugs or devices that have large sales, large safety
Publikováno v:
Expert Opin Drug Saf
INTRODUCTION: Ciprofloxacin, levofloxacin, and moxifloxacin belong to the fluoroquinolone class of antibiotics and are amongst the most commonly prescribed antibiotics. In 2018 and 2019, Food and Drug Administration (FDA) and the European Medicine Ag