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Our design is motivated by a B-cell Non-Hodgkin Lymphoma trial evaluating multiple dosing regimens within multiple disease subtypes.
Multiple dosing regimens of interferon were studied with the most common being thrice weekly interferon-alfa for a minimum of 22 weeks.
Only phase III studies were included to reduce potential noise related to small sample size and multiple dosing regimens.
Six trials in acute pain were omitted because of design issues, like the use of different pain measures or multiple dosing regimens.
Previous studies have been conducted using multiple dosing regimens and variable doses to determine the plateau concentration of lutein in the bloodstream.
Various multiple dosing regimens were simulated to elicit the erythropoietic response at 10 and 30 mg/kg doses orally administered QD, Q2D, and Q3D over 1 week.
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PK was assumed to be linear within each multiple dosing regimen.
Two studies administered a single dose of gabapentin preoperatively, and three studies used a multiple dosing regimen.
Figure 5a, b indicates the 5, 50, and 95 percentile values of day 1 of the multiple dosing regimen; Figure 5c, d indicates the same for day 14.
When tumors reached 100 mm, the mice received EZN-2208 or CPT-11 at their respective MTDs (single or multiple dosing regimen).
Although the studies were preliminary in nature, we have shown that this MNT as well as another MNT incorporating the same DTox-HMP-NLS modules but with α-melanocyte-stimulating hormone as the ligand module were not toxic to mice when administered either as a single injection at the maximum achievable dose or when administered in multiple dose regimens [6].
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