Pharmacokinetic and pharmacodynamic comparison of two

Table 2 Pharmacokinetic parameters calculated from the PEG-IFN concentration in serum.

Parameter	Formulation A N = 15	Formulation B N = 15	p	90% CI
AUC (pg.h/mL)	53623 ± 37517	44311 ± 26035	0.125	(0.66 - 1.03)
Cmax (pg/mL)	333 ± 205	271 ± 206	0.26	(0.62 - 1.06)
Tmax (h)	48 ± 24	48 ± 48	0.80	(0.78 - 1.33)
λ (h^-1)	0.011 ± 0.004	0.014 ± 0.008	0.38	(0.90 - 1.52)
t_1/2 (h)	72.4 ± 28.1	64.8 ± 29.6	0.45	(0.71 - 1.12)
MRT (h)	135 ± 43	123 ± 41	0.38	(0.78 - 1.06)
CAV	0.008 ± 0.003	0.008 ± 0.003	0.56	(0.93 - 1.17)
CL/F (L/h)*	7.9 ± 12.4	7.4 ± 15.6	0.16	(0.57 - 1.70)
Vd/F (L)*	720 ± 1205	841 ± 2130	0.69	(0.61 - 2.23)
MAT (h)	33.0 ± 13.2	29.1 ± 14.0	0.26	(0.77 - 1.15)
HVD (h)	126 ± 66.5	153 ± 113	0.34	(0.89 - 1.56)

Data are reported as mean ± standard deviation, except for Tmax expressed as median ± quartile range.
CI: confidence intervals of the mean Test/Reference ratio
One volunteer (#13) was excluded from the pharmacokinetic comparison (see text)
* Parameters corrected by corporal surface
p: Paired t test between groups, except for Tmax (Wilcoxon's test)