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On March 15th the plant reported a dose at the perimeter of 11.9mSv an hour (though this dropped back to 6mSv), meaning a worker's maximum permitted dose for a year would be exceeded in a single shift.
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In an open-label extension study by Kremer et al, 20 RA patients with MTX-IR treated with ETN+MTX were permitted dose reductions for MTX or, in some cases, corticosteroid after at least 3 months of combination therapy.
Reduction in the bevacizumab dose was not permitted; dose delays were allowed for reversible and preventable toxicities.
This concern probably does not explain our results, as haloperidol tended to be used at the upper end of the permitted dose in most patients for most of the time it was infused.
In LL3, pharmacokinetic assessments demonstrated similar geometric mean plasma concentrations of afatinib for all permitted dose groups (20, 30, 40, and 50 mg) after tolerability-guided dose adjustments [ 66].
Patients were monitored for toxicity; 1-week dosing interruptions were permitted for dose-limiting toxicities.
For both lenalidomide and dexamethasone, dose escalation was not permitted after dose reduction.
Low-dose (70 100 mg/d) aspirin for anti-thrombotic therapy is permitted if doses are stable for the month prior to screening and remain stable throughout the study period.
Unscheduled visits were permitted for additional dose titration as needed.
Alternatively, myeloid growth factor support for secondary prophylaxis of neutropenia was permitted without dose modification.
Investigators were permitted to increase the dose for LY2140023 patients to 160 mg/day (80 mg BID), with no intermediate dose.
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