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

AAPS Open

Table 3 Summary statistics of geometric mean ratios derived from ANOVA of simulated data

	Predicted parameter	N per trial	No. of simulation	Mean	Std Dev	5^th percentile	95^th percentile
SD	AUC_0–168 h	10	1000	104.25	1.13	104.14	106.34
SD	C_max	10	1000	137.47	11.0	135.99	157.15
SS	AUC_0–24 h,ss	10	1000	103.53	1.07	103.45	105.58
SS	C_max,ss	10	1000	111.30	3.56	110.69	118.10

AUC Area under the concentration–time curve, C_max Maximum plasma concentration, SD Single dose, SS Steady state