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In a group as heterogeneous as sepsis patients, the currently approved dose and duration of administration (24 μg/kg per hour for 96 hours) might not be optimal in some individuals.
Eligible patients will receive DrotAA either at the normal, currently approved dose and duration of administration ('standard therapy') or at a higher dose with variable infusion duration or variable infusion duration only ('alternative therapy').
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The approved dose is 9 mg/m intravenously (given on days 1 and 15).
The approved dose in the EU is 100 μg administered as a daily subcutaneous injection in the abdomen for a duration of up to 2 years.
The dose of irinotecan used in the FOLFIRI regimen (150 mg/m) was the approved dose in Japan, but is slightly lower than that used in the USA and Europe (180 mg/m), although, as discussed above, the median PFS durations in our study were similar to other recent studies in this setting.
Only patients with depressive symptoms considered nonresponsive or partially responsive to a single treatment course of an adequate dose (approved) and duration (≥6 weeks) were eligible for the study (stage I (Thase and Rush, 1997) and stage A (Souery et al., 1999) criteria).
We have also compared marketed and approved doses of the various drugs.
Dose and duration are also relevant.
We cured acute leukaemia in mice in 1977 with drugs that we are still using in exactly the same dose and duration today in humans with dreadful results.
The best drug, the optimal dose and duration of therapy for a particular patient are not determined directly by a study involving a large population".
The dose and duration of steroids are highly variable.
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