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4.6 + 0.12

5.6 + 0.22 *

17.8 + 0.20*

48.1 +

2.27 *

"*, Mean value ± S.E.M. for 10 individual subjects significantly different from 0.98 ISI thromboplastin means at 5% level by i-test, separately by increasingly ISI value for individual rabbit thromboplastins.

"*, Mean value ± S.E.M. for 10 individual subjects significantly different from 0.98 ISI thromboplastin means at 5% level by i-test, separately by increasingly ISI value for individual rabbit thromboplastins.

closely approximate the PT/control ratio and give a true estimate of the anti-coagulated state.

Table 5 indicates the maximum change in PT/control ratio and INR using thromboplastins with increasing ISI values (1.24 to 2.21). Changes in the PT/control ratio were modest at drug concentrations that produced increases of fourfold or less, the maximum targeted therapeutic PT value for clinical trials. The mean PT/control ratio in human samples increased maximally from 2.7 to 3.1 at twice the therapeutic dose (0.6 |g/mL). Absolute PT and PT ratios compared to baseline values were only modestly different using throm-boplastin from various manufacturers, sources (human recombinant versus rabbit), and ISI. This finding indicates that absolute PT or PT/control ratio were more effective biomarkers of FXa inhibitor concentration than was INR.

TABLE 5 Comparison of PT/Control Ratio and International Normalization Ratio in Plasma Samples Containing Increasing Concentrations of Factor Xa Inhibitor"
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