PowerTOST (version 1.5-3)

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 a string. Implemented settings are for "EMA", "FDA", "HC", and "GCC". The former (inofficial) settings for "ANVISA" are 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 scaled ABEL power / sample size functions for
# }

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