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.
- Is the proportion of affected fetus (f/n) dose related? Is litter size (n) dose related? If so,
how will you determine if the proportion of affected fetuses (f/n) is dose related?
- Do you view 0/7
as a different outcome than 0/17? If so, how would you treat these data?
- Is the proportion of affected litters dose related?
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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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