Systematic within-person variation in the bioavailability of various drugs in healthy volunteers
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The relative bioavailability of 22 registered pharmaceutical specialities compared to one or more generic equivalents was investigated in 50 human volunteers using randomized cross-over trials. The data were reassessed with regard to individual behaviour in different experiments and with different drugs. The pharmacokinetic behaviour (Cmax, Tmax, and AUCo–t) of the volunteers exhibited consistent patterns, which were not attributable to chance. It is concluded that the cross-over design is necessary in conducting relative bioavailability studies.
Key wordsBioavailability pharmacokinetic behaviour cross-over design bioequivalence intra-individual differences
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