Skip to main content

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