Zobrazeno 1 - 10 of 104 pro vyhledávání: '"Gail A Van Norman"'
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Akademický článek
Self-reported functional status predicts post-operative outcomes in non-cardiac surgery patients with pulmonary hypertension.
Autor: Aalap C Shah, Kevin Ma, David Faraoni, Daniel C S Oh, G Alec Rooke, Gail A Van Norman
Publikováno v: PLoS ONE, Vol 13, Iss 8, p e0201914 (2018)
BACKGROUND:Pulmonary hypertension (PHTN) is associated with increased post-procedure morbidity and mortality. Pre-procedure echocardiography (ECHO) is a widely used tool for evaluation of these patients, but its accuracy in predicting post-procedure
Externí odkaz: https://doaj.org/article/7609878ca684477191aa7489c9a65a16
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3
Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials
Autor: Gail A. Van Norman
Publikováno v: JACC: Basic to Translational Science
Summary Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S. Food and Drug Agency approval based on early phase trials alone. These developments point to new chal
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51e17e57e5b0cd0a23203803446e8792
https://doi.org/10.1016/j.jacbts.2021.09.005
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4
Update to Drugs, Devices, and the FDA
Autor: Gail A. Van Norman
Publikováno v: JACC: Basic to Translational Science
Summary Two major legislative actions since 2015, the 21st Century Cures Act of 2016 and the U.S. Food and Drug Administration (FDA) Reauthorization Act of 2017, contain significant provisions that potentially streamline drug development times, and b
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::73a673686660dfd43205d07192771b5c
http://europepmc.org/articles/PMC7444905
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5
'Warp Speed' Operations in the COVID-19 Pandemic
Autor: Gail A. Van Norman
Publikováno v: JACC: Basic to Translational Science
Summary The COVID-19 (coronavirus disease-2019) pandemic has presented unprecedented challenges to regulatory organizations, the biotech and pharmaceutical industry, and the publishing industry. This Translational Perspectives paper attempts to highl
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::facfff4bcd8c19ed9bf4d49cfaf04028
http://europepmc.org/articles/PMC7393415
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6
Limitations of Animal Studies for Predicting Toxicity in Clinical Trials
Autor: Gail A. Van Norman
Publikováno v: JACC: Basic to Translational Science, Vol 4, Iss 7, Pp 845-854 (2019)
JACC: Basic to Translational Science
Summary: Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays i
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8176f0152ffdf0d9a595ade8d09f4734
https://doi.org/10.1016/j.jacbts.2020.03.010
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7
Ethical Issues in Organ Transplantation at End of Life
Autor: Wendy M. Suhre, Gail A. Van Norman
Publikováno v: Anesthesiology Clinics. 38:231-246
End-of-life vital organ transplantation involves singular ethical issues, because survival of the donor is impossible, and organ retrieval is ideally as close to the death of the donor as possible to minimize organ ischemic time. Historical efforts t
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::3344fd9673a418b30820ea53c1ffc807
https://doi.org/10.1016/j.anclin.2019.10.009
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9
Phase II Trials in Drug Development and Adaptive Trial Design
Autor: Gail A. Van Norman
Publikováno v: JACC: Basic to Translational Science, Vol 4, Iss 3, Pp 428-437 (2019)
JACC: Basic to Translational Science
Summary: Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptiv
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::08f077d6bccfaf5c5f8970916edfda09
https://doi.org/10.1016/j.jacbts.2019.02.005
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