Testing for bioequivalence of highly variable drugs from TR-RT crossover designs with heterogeneous residual variances.

Abstract

Traditional bioavailability studies assess average bioequivalence (ABE) between the test (T) and reference (R) products under the crossover design with TR and RT sequences. With highly variable (HV) drugs whose intrasubject coefficient of variation in pharmacokinetic measures is 30% or greater, assertion of ABE becomes difficult due to the large sample… (More)
DOI: 10.1002/pst.1816

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