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Table 3 Experiment 2: losses after intravenous injection, relative concentrations and actual doses after direct subcutaneous injection of different formulations of interferon β-1a

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

Formulation

Losses after intravenous injection

Relative concentration (direct subcutaneous injection)

Actual dose [MIU] (direct subcutaneous injection)

 

Median

Range

Median

Range

Median

Range

Biferonex® HSA-free

5.6 %

0.6 %

167 %

3 %

18.01

0.02

Biferonex® + HSA

13.6 %

6.5 %

173 %

8 %

16.74

0.05

Rebif®

5.7 %

9.1 %

131 %

19 %

18.33

0.01

  1. Losses observed after injection through the infusion line (intravenous) versus direct injection (subcutaneous) of three different formulations of interferon β-1a at a dose of 18.0 MIU. Relative concentrations are expressed with reference to nominal levels