Statistical considerations in bioequivalence trials
Journal
Communications in Statistics - Theory and Methods
Journal Volume
23
Journal Issue
2
Pages
325-339
Date Issued
1994
Author(s)
Chow S.-C.
Abstract
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 Cmax∗.
Type
journal article