Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets

AAPS Open

Table 1 Population pharmacokinetic parameter estimates for applesauce covariates added

Parameter^a	Structural model parameters		Interindividual variability (CV%)
Parameter^a	Estimate	RSE%	Estimate	RSE%
COV_applesauce on F	0.0254	54.3	100.6	35.0
COV_applesauce on KA	0.406	26.6	155.5	0.144
COV_applesauce on ALAG	− 0.0352	18.3	185.0	0.07

ALAG Absorption lag time, COV Covariate, CV Coefficient of variation, F Oral bioavailability, KA Absorption rate constant, RSE Relative standard error
^aParameters defined as Parameter_applesauce = Parameter_reference*(1 + COV_applesauce*exp(IIV_{COV,applesuace})