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

In Detlew/PowerTOST: Power and Sample Size for (Bio)Equivalence Studies

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

Detlew/PowerTOST documentation built on March 26, 2024, 12:18 a.m.