title: Statistical evaluation of the scaled criterion for drug interchangeability.
abstract: As more and more generic drug products become available in the marketplace, it is a concern whether these generic drug products can be used interchangeably in terms of their quality, safety, and efficacy. The United States Food and Drug Administration (FDA) indicates that an approved generic drug product can serve as a substitute for the innovative drug product. The FDA, however, does not indicate that approved generic drug products can be used interchangeably even if they are bioequivalent to the same innovative drug product. In the past decade, several criteria for assessing interchangeability were proposed in regulatory guidances and/or literature. Chow, Xu, and Endrenyi proposed a scaled criterion for drug interchangeability (SCDI), which takes both intra-subject variability and subject-by-drug variability into consideration. In this paper, the performance of this criterion is statistically evaluated by deriving the upper confidence limit of the test statistic and extrapolating expression of the power to facilitate sample size calculation. The performance of SCDI is also compared with that of the criterion for assessment of individual bioequivalence (IBE) for addressing drug switchability recommended by the FDA, which also takes into account the subject-by-drug variability, under various parameter specifications.
authors.affiliation: a Department of Biostatistics and Bioinformatics , Duke University School of Medicine , Durham , North Carolina , USA.
authors.forename: Jianghao
authors.initials: J
authors.lastname: Li
authors.affiliation: a Department of Biostatistics and Bioinformatics , Duke University School of Medicine , Durham , North Carolina , USA.
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
mesh_terms: D016568:Drugs, Generic / Q000592:standards*; D006801:Humans; D012107:Research Design; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic
keywords: Interchangeability; confidence limits; individual bioequivalence; sample size; scaled criterion for drug interchangeability