. Author manuscript; available in PMC: 2012 Jul 25.

Published in final edited form as: Clin Pharmacol Ther. 2011 Dec 28;91(2):234–242. doi: 10.1038/clpt.2011.216

Table 4.

Pharmacokinetic similarity analysis for the epoetin alpha data

		Formulation R		Formulation T		T/R

PK parameter	Method	Geometric mean	CV (%)	Geometric mean	CV (%)	Ratio (%)	90% CI (%)
AUC_ss (h.mIU/mL)	NLMEM	9,522.4	21.4	8,643.5	21.5	91.1	[83.6; 99.3]
AUC_ss (h.mIU/mL)	NCA	8,651.5	20.5	7,755.3	29.7	89.6	[85.7; 93.8]
C_max (mIU/mL)	NLMEM	2,024.4	20.3	1,916.9	20.3	94.7	[87.5; 102.6]
C_max (mIU/mL)	NCA	2,213.7	18.7	2,143.9	18.0	96.8	[93.3; 100.5]

AUC_ss, area under the curve between for the 11^th dose; C_max, maximal concentration for the 11^th dose; CV, coefficient of variation; CI, confidence interval; NCA, non-compartmental analysis; NLMEM, nonlinear mixed effects model; PK, pharmacokinetic.