Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
Statistical Evaluation of Bioequivalence Studies - BEBAC ...
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Parallel Groups• Design Issues• EMEA NfG on BA/BE• 3.2.4 Genetic phenotypingPhenotyping and/or genotyping <strong>of</strong> subjects should beconsidered for […] all studies using parallel group design.If a drug is known to be subject to major genetic polymorphism,studies could be performed in panels <strong>of</strong> subjects <strong>of</strong> knownphenotype or genotype for the polymorphism in question.• Since the comparison is based on inter-subject effects,• stratify groups for phenotype/genotype.• run two studies <strong>of</strong> the respective phenotype/genotype (?)• one study <strong>of</strong> the major phenotype/genotype (?)Dissolution Testing, Bioavailability & <strong>Bioequivalence</strong> | Budapest, 24 May 2007 33
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