Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
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Nuisance: sequence effect• In a ‘standard’ 2×2 cross-over design• the sequence effect is confounded with• the carryover effect, and• the formulation-by-period interaction.• Therefore, a statistically significant sequenceeffect could indicate that there is• a true sequence effect,• a true carryover effect,• a true formulation by period interaction, or• a failure <strong>of</strong> randomization.Dissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 63
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