PowerTOST (version 1.2-09)

scABEL: Helper function to calculate the (widened) scaled BE acceptance limits

Description

The (widened) scaled BE acceptance limits are calculated according to the regulatory settings of EMA, FDA, ANVISA or via user defined constants.

Usage

scABEL(CV, regulator = c("EMA", "ANVISA", "FDA", "USER"), r_const, CVswitch, CVcap)

Arguments

CV

Coefficient of variation (of the Reference) as ratio

regulator

Regulatory body settings for the widening of the BE acceptance limits. Defaults to design="EMA".

r_const

Regulatory constant for wideneing.

CVswitch

CV for switch to the widened ABEL.

CVcap

CV for cap of widening.

Value

• Returns a vector of lenghth 2 if one CV is given or a matrix if CV is given as vector with named components "lower" and "upper" of the scaled acceptance limits.

Details

r_const, CVswitch and CVcap must be given if regulator=="USER". Otherwise these arguments may be missing.

See Also

power.scABEL, sampleN.scABEL

Examples

scABEL(CV=0.3, regulator="EMA")
# should give the usual limits:
# lower  upper
#  0.80   1.25
scABEL(CV=0.4, regulator="EMA")
# should give the widened limits:
#   lower     upper
# 0.746177 1.340165