An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence.

ABSTRACT: Reference-scaled average bioequivalence (RSABE) has been recommended by Food and Drug Administration (FDA), and in its closely related form by European Medicines Agency (EMA), for the determination of bioequivalence (BE) of highly variable (HV) and narrow therapeutic index (NTI) drug products. FDA suggested that RSABE be evaluated by an approximating procedure. Development of an alternative, numerically exact approach was sought. A new algorithm, called Exact, was derived for the assessment of RSABE. It is based upon the observation that the statistical model of RSABE follows a noncentral t distribution. The parameters of the distribution were derived for crossover and parallel-group study designs. Simulated BE studies of HV and NTI drugs compared the power and consumer risk of the propose

SUBMITTER: Tothfalusi L 

PROVIDER: S-EPMC4779113 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature