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Table 4 Trial A: bias and variability in the amount of injected Biferonex® at different dose levels

From: Biases affecting injected doses of an experimental drug during clinical trials

Dose level [MIU] TW i W i Median relative bias Route
[mg] [mg] Bias [%] Range
0.5 41.6 20.8 −73.6 % 205.1 % Intravenous
1.0 83.2 50.5 −51.0 % 119.8 % Intravenous
1.5 124.8 106.5 −15.1 % 30.3 % Subcutaneous
2.0 166.4 154.3 −8.1 % 23.9 % Intravenous
3.0 249.6 239.7 −5.4 % 9.7 % Subcutaneous
4.0 332.8 326.2 −1.3 % 11.8 % Intravenous
6.0 499.2 529.1 6.1 % 4.0 % Subcutaneous
  1. Biases evaluated during Trial A with Biferonex® HSA-free at each dose level. TW i = weight of solution to inject; W i = weight actually injected, bias = median of (W i − TW i)/TW i, with the range covered by individual measures