منابع مشابه
Validation of Instruments for Assessing Drug Safety Management During the Conduction of Clinical Trials
Background The management of drug safety with the collection of reliable safety data during the conduction of clinical trials conduct is essential for the registry and marketing of products. The systematic evaluation of this process, based on objective measures, requires the application of quality instruments. This study was aimed to design and validate eight instruments through the components ...
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Efalizumab was approved for moderate to severe psoriasis in 2003 based on studies in approximately 2700 patients, of whom only 218 were exposed to the drug for more than 1 year. In 2009, after more than 46,000 patients were exposed to efalizumab, the drug was withdrawn from the market after 3 confirmed and 1 suspected case of progressive multifocal leukoencephalopathy (PML) were spontaneously r...
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a Professor and Director, Program in Economics and Health Policy, The George Washington University School of Public Health and Health Services, Department of Health Policy b Assistant Research Professor, Department of Health Policy c Research Assistant, Department of Health Policy d Research Assistant, Department of Health Policy e Commonwealth Fund Harkness Fellow in Health Policy, Department ...
متن کاملAssessing Hospital Safety Index in the Iranian Hospitals Against Disasters
Introduction: Hospital preparedness for accidents and disasters is vital in maintaining and promoting community health. However, the country's hospitals are not well prepared for disasters. The hospital safety index (HIS) was 42% in Iranian hospitals in 2014. This study aims to investigate the HSI in Iranian hospitals in 2020 and to provide solutions to improve it. Methods: This cross-sectiona...
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Among the thorny issues confronting newlyconfirmed FDA Commissioner Gottlieb is the unresolved rulemaking proposal to permit generic drug manufacturers to amend safety warnings in their labels without prior FDA approval. At present, only pioneer branded manufacturers holding New Drug Applications may make such amendments to respond to newlydiscovered evidence of a reasonable association between...
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ژورنال
عنوان ژورنال: BMJ
سال: 2005
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.330.7490.539-b