Jukka Vuorinen

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Bioavailability data arising from a standard two-period cross-over study are routinely analysed to establish bioequivalence between test and reference formulations. Current regulatory guidelines only require evidence of equivalence in average bioavailability for the assessment of bioequivalence. Under normality assumptions, this is achieved by demonstrating(More)
The two-period crossover design is the most commonly used study design for bioequivalence of one test formulation to be assessed in comparison to one reference formulation. Consequently, in this paper, all derivation is based on this particular design. It is assumed that for the underlying statistical model the usual assumptions of normality and additivity(More)
The digital world provides various ethical frames for individuals to become ethical subjects. In this paper I examine – in a Foucauldian and Luhmannian way – the differences between three systems of communication: the proprietary, the open/free and the cracker system. It is argued that all three systems provide a different set of ethical codes which one can(More)
The two-period cross-over design with two sequences of drug administration is a standard experimental design when bioequivalence of one test formulation is to be assessed in comparison with a reference formulation. Previously, an approach based on Fieller's confidence interval has been presented for the assessment of average bioequivalence under this(More)
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