PowerTOST (version 1.4-6)

CVwRfromU: CVwR from the upper expanded limit (ABEL)

Description

Calculates the CV (coefficient of variation) of the reference from the upper expanded limit of a BE study (replicate design for ABEL). Useful if no CVwR but the expanded limits were given.

Usage

CVwRfromU(U, regulator = "EMA")
U2CVwR(U, regulator = "EMA")

Arguments

U

Upper expanded limit. Must be >1.2500 and <1.4319 (if regulator="EMA") or <1.5000 (if regulator="HC").

regulator

Regulatory body<U+2019>s settings for expanding the BE acceptance limits, given as a string from the choices "EMA" or "HC". Defaults to regulator="EMA".

Value

Numeric value of the CVwR as ratio, where CVwR = sqrt(exp((log(U)/r_const)^2)-1).

Details

Only the upper expanded limit is supported since it offers one more significant digit than the lower expanded limit.

Examples

# NOT RUN {
# Given the upper expanded limit and using the defaults
CVwRfromU(U=1.38)
# should give [1] 0.44355, i.e., a CVwR ~ 44%
# Upper limit from a study according the Health Canada<U+2019>s rules
CVwRfromU(U=1.48, regulator="HC")
# should give [1] 0.55214
# }