. 2016 Jul 13;5(2):169–182. doi: 10.1007/s40120-016-0048-2

Table 1.

Reproductive and developmental toxicity studies conducted with daclizumab in cynomolgus monkeys

Type of study	Duration of dosing	Doses (mg/kg)	NOAEL (mg/kg)^a	Multiple of human exposure^a
Male fertility and early embryonic development	9 weeks (~60 days to cover all stages of spermatogenesis)	0	200	102
		10
		50
		200
Female fertility and early embryonic development	9 weeks (~2 menstrual cycles)	0	200	85
		10
		50
		200
Embryo–fetal development	GD20–50 (period of organogenesis)	0	200	140
		10
		50
		200
Pre- and postnatal development	GD50—parturition GD160 ± 10	0	50	55
Pre- and postnatal development	GD50—parturition GD160 ± 10	50	50	55

GD gestation day, NOAEL (reproductive and developmental toxicity) no-observed-adverse-effect level

^aBased on human exposure (area under curve for days 0–28) in OBSERVE, a pharmacokinetic study of daclizumab in patients with multiple sclerosis [31]