scaledBound: Widened Bound for Scaled Average Bioequivalence

In BE: Bioequivalence Study Data Analysis

Widened Bound for Scaled Average Bioequivalence

Description

It calculates widened bound for scaled average bioequivalence.

Usage

scaledBound(CV = 40, k = 0.76, digits = 4)

Arguments

CV	coefficient of variation in percent
k	0.76 is for EMA and Korea MFDS. US FDA uses 0.893. When CV is 30%, bound becomes (0.8, 1.25). Most regulatory bodies do not use a more accurate value.
digits	Korea MFDS use 4 digits only, while other regulatory bodies use more decimal values.

Details

CV must be larger than 30%. For EMA and Korea MFDS (k = 0.76) the CV is capped at 50% for the widening, while US FDA (k = 0.893) is not capped. US FDA uses this widened bound for both AUClast and Cmax, while EU EMA and Korea MFDS use this for Cmax only.

Value

widened bound for scaled average bioequivalence

Author(s)

Kyun-Seop Bae <[e-mail]>

Examples

scaledBound(30)
scaledBound(35)
scaledBound(40)
scaledBound(45)
scaledBound(50)

BE documentation built on July 29, 2026, 5:07 p.m.