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

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

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.

Author

D. Labes

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.

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