Favorite Datasets from Early (and Late) Phases of Drug Research

Oral Teratogenic Study in Mice

Part 4 - Table 1


One hundred adult female mice were assigned randomly to treatment with either a negative control (0.5% aqueous methylcellulose) or one of three graded doses (8, 80, 800, mg/kg) of an investigational drug (25 animals/treatment). Prior to dosing, the females were mated with untreated male mice; one male to one female. (One female in each of the Negative Control and 800 mg/kg dose groups and two females in the 80 mg/kg dose group were not impregnated). Dosing was performed orally, once daily, by metal gavage tube on Days 6 through 15 of gestation. On Day 17 of gestation the female mice were sacrificed. Fetuses were examined for external, visceral, and skeletal malformations. These evaluations were conducted blindly. The proportion (f/n) of fetuses (f) per litter (n) with >= 1 skeletal malformation was recorded.

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Part 4 - Table 1
Oral Teratogenic Study in Mice
Proportion (f/n) of Fetuses (f) per Litter (n)
with >= 1 Skeletal Malformation
Dose (mg/kg)
Control 8 80 800
0/7 0/10 0/11 0/11
0/8 3/10 0/11 0/11
0/9 0/11 0/11 0/11
0/10 0/11 0/11(a) 2/11(a)
0/10 0/12 0/12 0/12
0/11 0/12 0/12 1/12
0/11 0/12 0/12(a) 0/13
0/11 0/12 1/12 0/13
1/11 0/12 2/12 0/13
0/12 0/12 0/13 0/13
0/12 0/13 0/13 1/13
1/12 0/13 0/13 2/13
0/13 0/13 1/13 0/14
0/13 1/13 0/14 0/14
0/13 0/14 0/14 0/14
0/13 0/14 0/14 1/14
0/13 0/14 1/14 1/14
1/13 0/14 0/15 0/15
0/14 1/14 1/15 1/15(a)
0/14 1/14(a) 2/15 0/16
0/14 0/15 0/16 0/16
0/14(a) 0/15 0/16 1/16
1/14 0/15 0/16 0/17
0/16 0/15(a) 0/17
0/17

(a) One additional fetus was born dead but was not
examined for skeletal malformations.


Source:

Bradstreet, T.E. and Liss, C.L. (1995) "Favorite Data Sets from Early (and Late) Phases of Drug Research - Part 4." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 27, 2010 - THS