Statistical considerations in bioequivalence trials
We discuss the statistical issues in evaluation of bioequivalence addressed by the FDA Bioequivalence Hearing (1986) and Guidance on Statistical Procedures for Bioequivalence Studies released by the Division of Bioequivalence, Office of Generic Drugs of FDA (1992). They are logarithmic transformation of pharmacokinetic data, sequence effect, and outlying data. We also compare the additive model with the multiplicative model, examine the relationship between intrasubject variability and interchangeability, describe the concept of population versus individual bioequivalence, and investigate the distributions of AUC and C max . © 1994, Taylor & Francis Group, LLC. All rights reserved.
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