reg_const {PowerTOST} | R 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 |
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 |
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 |
|
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