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Brain permeability can be described by the brain-to-plasma maximum concentration ratio Cmax,br/ Cmax,pl, for each patient (Supporting Information Table S2).
When considering the maximum concentration, however, the ratio cmax tumour/ cmax connective tissue of FU was significantly lower than that of all other evaluated compounds (ratio cmax tumour/ cmax connective tissue of capecitabine vs FU: P=0.05; DFCR vs FU: P=0.03; DFUR vs FU: P=0.05).
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According to the results previously reported for dexamethasone, another corticosteroid widely used for uveitis treatment, after a single oral dose of 7.5 mg the drug penetrates into the posterior segment in humans and the ratio mean Cmax vitreous/ Cmax plasma was approximately equal to 0.084.
Accumulation ratio of Cmax and AUC of days 1 and 14 were calculated (RA, Cmax, and RA,AUC).
The % prediction error (%PE) in fed-to-fasted ratio of Cmax and AUC were less than 5% for all formulations except for the Cmax of Nifedicron (%PE = −29.6%).
Propranolol 80 mg (n =1): Ratio for Cmax = 14 and ratio for AUC = 24.
Metoprol 100 mg (n = 1): Ratio for Cmax = 8 and ratio for AUC = 23.
The mean ratio of Cmax was 235% comparing CORAL® with Adalat® OROS under these conditions.
The data in Table 1 represent the ratio of Cmax values at 4, 20 and 40% alcohol when compared to the control (0% alcohol).
The 90% confidence intervals for the ratio of Cmax (0.86 1.06), AUC0−t (0.96–1.04) and AUC0−inf (0.97–1.05) values for the test and reference products are within the 0.80 1.25 interval proposed by FDA and EMEA.
The 90% confidence interval for the ratio of Cmax (87.5 103.8%), AUC0 t (89.3–107.2%) and AUC0 ∞ (89.7–106.0%) values for the test and reference products is within the 80 125% interval, proposed by FDA, EMEA and ANVISA.
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