Table 4.

Assessment of dose proportionality for GLA5PR GLARS-NF1 from 150 to 600 mg using the power model^a

Dependent variable	Model variable	Estimate (β)	P-value	90% CI	Equivalent limitsb
AUClast (h⋅ng−1⋅mL−1)	ln(Dose)	1.0032	<0.0001	0.9130–1.0935	0.8390–1.1610
Cmax (ng/mL)	ln(Dose)	0.9246	<0.0001	0.8241–1.0252	0.8390–1.1610

Notes:

^aPower model: ln(pharmacokinetic [PK] parameter) = α+β*ln(Dose)+ε.

^bEquivalent limits: 1+{ln(0.8)/ln(dose ratio)} <β<1+{ln(1.25)/ln(dose ratio)}; Dose ratio: high dose/low dose.

Abbreviations: AUC_last, area under the serum concentration-time curve from time zero to the time of the last measured concentration; C_max, maximum serum concentration.