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

View source: R/scABEL.R

reg_constR Documentation

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.

Note

The former inofficial regulatory settings for regulator="ANVISA" are covered by regulator="EMA" (BEBA Forum).

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.

Author(s)

D. Labes

References

BEBA Forum. May 2016. online

Health Canada, Therapeutic Products Directorate. Comparative Bioavailability Standards: Formulations Used for Systemic Effects, 2.1.1.8 Highly variable drug products Ottawa, 08 June 2018. online

Examples

# 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

PowerTOST documentation built on May 29, 2024, 4:40 a.m.