PowerTOST (version 1.4-7)

reg_const: Constructor of an object with class 'regSet' containing the regulatory settings for ABEL

Description

This function may be used to define regulatory settings not implemented yet in PowerTOST.

Usage

reg_const(regulator, r_const, CVswitch, CVcap, pe_constr)

Arguments

regulator

Name of the regulatory body as character. Implemented settings are for "EMA", "FDA", "HC". The former (inofficial) settings for "ANVISA" are now covered by the EMA settings. In case of regulator="USER" the other arguments must be given. Otherwise they may be missing.

r_const

Regulatory constant.

CVswitch

CV to switch to the widened acceptance limits.

CVcap

CV for capping the widening of the acceptance limits.

pe_constr

Logical. Shall pe constraint be applied? Defaults to TRUE.

Value

Returns an object of class 'regSet', a list with components

name

Name of the settings

CVswitch

see arguments

r_const

Regulatory constant

CVcap

see arguments

pe_constr

see arguments

est_method

"ANOVA" or "ISC"

Class 'regSet' has a S3 print method. The component est_method is automatically set to "ANOVA", except for regulator="FDA" or regulator="HC" where "ISC" is used.

Examples

# NOT RUN {
# to retrieve the EMA settings
reg_const("EMA")
# to define the old ANVISA settings
reg <- reg_const("USER", r_const=0.76, CVswitch=0.4, CVcap=0.5)
reg$name <- "Old ANVISA"
# Use reg as argument in the power / sample size functions
# }