Biases affecting injected doses of an experimental drug during clinical trials

Table 5 Trial B: biases and variability in the amount of injected formulations of interferon β-1a

Formulation	TW _i	W _i	Median relative bias		Route
Formulation	[mg]	[mg]	Bias [%]	Range	Route
Biferonex® HSA-free	1497.5	1593.9	6.8 %	2.7 %	Intravenous
Biferonex® HSA-free	1497.5	1608.4	7.5 %	4.8 %	Subcutaneous
Biferonex® + HSA	3060.0	2918.5	−4.2 %	7.2 %	Intravenous
Rebif®	1497.5	1538.7	2.9 %	2.4 %	Intravenous
Rebif®	1497.5	1548.8	3.6 %	2.9 %	Subcutaneous

Biases evaluated during Trial B with three different formulations at a dose of 18.0 MIU. 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

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