E
Ellis F. Unger
Researcher at Food and Drug Administration
Publications - 19
Citations - 2087
Ellis F. Unger is an academic researcher from Food and Drug Administration. The author has contributed to research in topics: Clinical trial & Clinical endpoint. The author has an hindex of 11, co-authored 16 publications receiving 1851 citations. Previous affiliations of Ellis F. Unger include Brigham and Women's Hospital.
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Journal ArticleDOI
A call for transparent reporting to optimize the predictive value of preclinical research
Story C. Landis,Susan G. Amara,Khusru Asadullah,Christopher P. Austin,Robi Blumenstein,Eileen W. Bradley,Ronald G. Crystal,Robert B. Darnell,Robert J. Ferrante,Howard Fillit,Robert Finkelstein,Marc Fisher,Howard E. Gendelman,Robert M. Golub,John L. Goudreau,Robert A. Gross,Amelie K. Gubitz,Sharon E. Hesterlee,David W. Howells,John R. Huguenard,Katrina Kelner,Walter J. Koroshetz,Dimitri Krainc,Stanley E. Lazic,Michael Levine,Malcolm R. Macleod,John M. McCall,Richard T. Moxley,Kalyani Narasimhan,Linda Noble,Steve Perrin,John D. Porter,Oswald Steward,Ellis F. Unger,Ursula Utz,Shai D. Silberberg +35 more
TL;DR: The main workshop recommendation is that at a minimum studies should report on sample-size estimation, whether and how animals were randomized, whether investigators were blind to the treatment, and the handling of data.
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Dabigatran and postmarketing reports of bleeding.
TL;DR: The FDA used the Mini-Sentinel database to determine that the actual rates of bleeding events were not higher with dabigatran than with warfarin.
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Anticoagulant options--why the FDA approved a higher but not a lower dose of dabigatran
TL;DR: The FDA believes that patients with nonvalvular atrial fibrillation should receive the higher dose of dabigatran, but a 110-mg regimen was also effective.
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Zolpidem and Driving Impairment — Identifying Persons at Risk
TL;DR: Because of new findings about next-day somnolence and sex differences in zolpidem clearance, the FDA has recommended lower doses of the drug, particularly for women, and emphasizes the greater risk of impairment with modified-release than with immediate-release formulations.
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Review of Maintenance Trials for Major Depressive Disorder: A 25-year Perspective From the US Food and Drug Administration
Silvana Borges,Yeh-Fong Chen,Thomas Laughren,Robert Temple,Hiren D. Patel,Paul A. David,Mitchell V. Mathis,Ellis F. Unger,Peiling Yang,Ni A. Khin +9 more
TL;DR: Antidepressant maintenance trials have a high rate of success, indicating a benefit of continuing drug treatment after initial response to an antidepressant, and this benefit appears to result mainly from a decreased rate of recurrent depression rather than from an effect of drug withdrawal in the placebo groups.