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controlling type i error in the reference scaled bioequivalence evaluation of highly variable drugs

descriptionPublicationkeyboard_double_arrow_right Article , Journal 12 Jun 2019Publisher:WileyJournal:Pharmaceutical Statistics, volume 18, pages 583-599 (issn: 1539-1604, eissn: 1539-1612,

Authors: Jordi Ocaña; Joel Muñoz;

doi: 10.1002/pst.1950

pmid: 31190418

controlling type i error in the reference scaled bioequivalence evaluation of highly variable drugs

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Abstract

Reference‐scaled average bioequivalence (RSABE) approaches for highly variable drugs are based on linearly scaling the bioequivalence limits according to the reference formulation within‐subject variability. RSABE methods have type I error control problems around the value where the limits change from constant to scaled. In all these methods, the probability of type I error has only one absolute maximum at this switching variability value. This allows adjusting the significance level to obtain statistically correct procedures (that is, those in which the probability of type I error remains below the nominal significance level), at the expense of some potential power loss. In this paper, we explore adjustments to the EMA and FDA regulatory RSABE approaches, and to a possible improvement of the original EMA method, designated as HoweEMA. The resulting adjusted methods are completely correct with respect to type I error probability. The power loss is generally small and tends to become irrelevant for moderately large (affordable in real studies) sample sizes.

Related Organizations

University of Barcelona
Spain
University of Concepción
Chile

Keywords

Legislation, Drug, Pharmaceutical Preparations, Therapeutic Equivalency, Research Design, Sample Size, Drugs, Generic, Humans, Probability

20 Research products, page 1 of 2

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PRINCIPLES OF STATISTICAL EVALUATION OF BIOEQUIVALENCE STUDIES IN THE CONTEXT OF CURRENT REGULATORY REQUIREMENTS AND LEGAL ACTS
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Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study
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