Topic: Reference-Scaled Approaches for Highly Variable Drugs

Sensitivity to Variance-Model Specification

Residual Diagnostics for Reference-Scaled Models

Reference-Replicate Contrasts for Estimating Variability

REML Estimation of the Reference Variance Component

Reporting a Reference-Scaled Bioequivalence Analysis

Qualifying a Drug for Reference Scaling

Interpreting Decisions Near the Scaling Boundary

Interpreting the Benefit and Limits of Scaling

Influential Observations in Scaled Bioequivalence

Instability of Reference Variance Estimates in Small Samples