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In 2009, Pfizer paid $301 million to settle allegations by the Justice Department that company representatives marketed the drug for unapproved uses and encouraged doctors "to prescribe the drug at substantially higher than approved dosages".
Therefore, in routine practice off-label use with doses higher than approved without sufficient evidence for better outcomes is frequent [ 20].
Objective To investigate the validity of recommendations in treatment guidelines to use higher than approved doses of oseltamivir in patients with severe influenza.
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More substantively, the poll found that more than two-thirds of city voters approve of how Mr. Kelly is handling his job, including 60 percent of blacks, far higher than approve of the current mayor.
This is a much higher percentage than approve of President Obama, the Senate, the House of Representatives, or the Supreme Court.
The Senate's DOE numbers are slightly higher than those approved earlier this month by the U.S. House of Representatives' spending panel.
Stopping the criticality subjected workers to higher than normally approved radiation doses and it was recognized that nuclear emergency response robots were needed to respond to future accidents.
The saxagliptin group was also heterogeneous and included patients treated with doses higher than the approved 2.5- and 5-mg once-daily doses.
In this context, the absence of prolongation of QTcF above 10 ms with the 600 μg dose (i.e., two- to four-fold higher than the approved EU doses) is a relevant finding for the safety profile of indacaterol.
Many included trials of biologic DMARDs at dosages higher than those approved by regulatory authorities, or did not account for differences in duration of exposure or differences arising from pooling data from populations not restricted to moderate to severely active rheumatoid arthritis.
The bortezomib dose was slightly higher than the approved 1.3 mg m−2 on the same schedule, but similar to that identified in phase I studies evaluating single-agent bortezomib administered on the same schedule (Aghajanian et al, 2002; Dy et al, 2005).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com