. 2015 Oct 12;4(2):93–104. doi: 10.1007/s40120-015-0033-1

Table 1.

Maternal body weight changes, fetal body weight differences, and skeletal ossification variations in the embryo/fetal development study in rats

DMF^a dosage (mg/kg/day)	Mean maternal body weight gain (g, %)^b,c	Mean fetal body weight (g, %)^c	Fetal skeletal variation: number of bones with ossification		Exposure margin^e
DMF^a dosage (mg/kg/day)	Mean maternal body weight gain (g, %)^b,c	Mean fetal body weight (g, %)^c	Hindlimb metatarsals^d	Hindlimb phalanges^d	Exposure margin^e
0	89.1	5.45	4.87	6.32	–
25	−1.8	+1.7	4.85	6.46	1-fold
100	−17.3**	+0.9	4.83	6.36	4-fold
250	−62.3**	−8.3**	4.43**	5.47*	11-fold

* P < 0.05 compared to mean control group value

** P < 0.01 compared to mean control group value

^aDelayed-release DMF (also known as gastro-resistant DMF); DMF dimethyl fumarate

^bBody weight gain during the dosing period gestation days 7–17

^cFor controls, group mean is shown. For treated groups, percentage difference from control values are shown. Statistical significance is based on actual data (not on the percent difference)

^dMean number of bones with ossification per fetus per litter

^eExposure margin ratios calculated based on human area under the curve exposure from United States Package Insert (USPI)