reg_const: Constructor of an object with class 'regSet' containing the...

Description Usage Arguments Value Note Author(s) Examples

View source: R/scABEL.R

Description

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

Usage

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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.

Note

The former inofficial regulatory settings for regulator="ANVISA" are covered by regulator="EMA" (see the BEBA Forum, May 2016).

The settings for CVcap of Health Canada (regulator="HC") were chosen in such a way that the limits of the acceptance range are capped nearly exact to 1/1.5 up to 1.5. Literally it is given rounded to 3 significant digits (Health Canada, April 18, 2016).

Author(s)

D. Labes

Examples

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# 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

Example output

EMA regulatory settings
- CVswitch            = 0.3 
- cap on scABEL if CVw(R) > 0.5
- regulatory constant = 0.76 
- pe constraint applied

PowerTOST documentation built on Jan. 18, 2021, 5:07 p.m.