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But what's striking is that though Crestor is more powerful than Lipitor, it is only slightly so at the highest approved dose.
In rodents treated with atomoxetine, seizure induction occurred only with doses several-fold higher than the highest approved dose for humans [ 143].
The highest approved dose of deferasirox is currently 30 mg/kg per d in many countries; however, some patients require escalation above 30 mg/kg per d to achieve their therapeutic goals.
Second, in accordance with study aims, patients received the highest approved dose of lanreotide Autogel (120 mg) and were included only if they had achieved biochemical control with 10 or 20 mg of octreotide LAR every 4 weeks.
Rosiglitazone was started at 4 mg in the morning and increased to 8 mg/day (4 mg in the morning and evening, the highest approved dose in the U.S. and Canada).
More recently, a lack of effect on QTcF has been reported with the LABA indacaterol using a parallel-group study design [42], although the highest dose examined (600 μg) represented only a twofold multiple of the highest approved dose in the EU [43].
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Dose escalation proceeded to the maximum planned dose level of sunitinib 50 mg and gemcitabine 1,250 mg m−2; further dose escalation was not tested as these are the highest approved doses for each agent individually.
In our study, upward dose adjustments for RA and the higher approved doses for AS and PsA (i.e., 5 mg/kg vs. 3 mg/kg for RA) could have contributed to higher medication costs for infliximab.
Like the single-agent pazopanib dose-finding study, the tolerable dose is higher than the currently approved dose, chosen on the basis of PK parameters and analyses of biological activity (Hurwitz et al, 2009).
Objective To investigate the validity of recommendations in treatment guidelines to use higher than approved doses of oseltamivir in patients with severe influenza.
For example, Drake et al. described four case reports of adrenal insufficiency (presenting as hypoglycaemia) reported in children with asthma who had received high doses (500 1,500 μg/day; maximum approved dose in children under the age of 12 is 200 μg/day in most countries) of FP for 6 months or longer [ 21].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com