Some Favorite Datasets from Early Phases of Drug Research

Oral Fertility Study in Male and Female Rats

Part 1 - Table 1


One hundred male and 100 female F0 generation rats were assigned randomly to treatment with either a Vehicle Control (0.5% aqueous methylcellulose), to one of three graded doses (30, 100, 300 mg/kg) of an antihypertensive drug, or to 300 mg/kg of the drug plus free access to 0.9% aqueous saline solution instead of water (20 rats of each sex per treatment group). Oral dosing q.d. by metal catheter continued for the males from 78 days prior to cohabitation, during pairwise cohabitation with treatment F0 generation females and until scheduled sacrifice. Oral dosing q.d. for the females continued 15 days prior to cohabitation with treated males, during cohabitation, and through Day 20 of gestation.

At delivery, the number of F1 generation pups alive (A), dead (D), and partially cannibalized (C), in each litter (Dam) was recorded as was the sex, initial body weight of each pup, and the length of gestation (Gest) as estimated to the nearest half day. Birth weights of some pups were inadvertently not recorded (N). From the pups remaining alive at the end of Day 1, four male and four female pups were randomly selected from each litter and their body weights on Days 7, 14, and 21 postpartum were recorded. During this time period, pups which either died, were sacrificed, were partially cannibalized or were found to be missing on or before Day 3 were replaced either by a littermate or a fostered pup of the same sex. In litters where less than four animals of each sex were born naturally to the dams, enough pups of the appropriate sex were fostered from another litter to increase the number to four. These replacement procedures were necessary to allow for similar living space and nursing competition in all of the litters.

Mean weights (gm) per litter of live pups (WT) are recorded for each sex in Table 1. Typical questions on which this study would focus are:

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Part 1 - Table 1
Oral Fertility Study in Male and Female Rats
Dose Dam Gest Sex A D C N WT 0 7 14 21
0 1 21.5 M 6 0 0 1 6.20 6.18 15.58 32.20 51.93
F 5 0 0 1 5.90 5.88 14.75 32.25 51.15
2 22.5 M 9 0 0 0 7.23 7.08 16.35 33.60 52.78
F 8 0 0 0 6.60 6.65 14.75 30.73 49.93
3 22.0 M 8 0 0 0 6.75 6.68 14.75 30.40 46.60
F 6 0 0 0 6.20 6.25 15.00 31.98 48.45
4 22.5 M 9 0 0 0 7.16 7.20 18.43 39.33 62.78
F 7 0 0 0 6.84 6.88 17.85 37.65 60.38
5 23.0 M 6 0 0 0 7.40 7.35 20.63 39.25 61.20
F 8 0 0 0 7.20 7.20 19.40 38.98 61.05
6 ---- M -- Dam not ---- ---- ----- ----- -----
F -- impregnated -- ---- ----- ----- -----
7 22.5 M 4 0 0 0 7.25 7.25 16.53 30.23 49.63
F 9 0 0 0 6.49 6.50 15.00 28.18 46.98
8 23.0 M 6 0 0 0 7.65 7.90 18.38 35.93 57.60
F 9 0 0 0 6.98 7.00 16.23 33.48 53.18
9 21.5 M 6 0 0 0 5.72 5.75 13.70 27.63 45.55
F 6 0 0 0 5.38 5.45 12.65 25.93 42.15
10 22.0 M 8 0 0 0 6.86 6.88 20.75 41.48 67.75
F 5 0 0 0 6.32 6.48 19.23 38.73 61.60
11 22.5 M 7 0 0 0 7.33 7.38 17.88 37.28 58.80
F 4 0 0 0 7.15 7.15 16.98 36.03 56.78
12 22.0 M 8 0 0 0 6.26 6.48 15.18 33.95 55.58
F 6 0 0 0 5.88 5.78 14.20 30.80 49.15
13 22.0 M 8 0 0 0 6.60 6.80 17.50 37.03 56.53
F 5 0 0 0 6.54 6.57 16.90 35.70 54.97
14 21.5 M 7 0 0 0 6.33 6.40 16.20 36.00 53.00
F 7 0 0 0 6.03 5.90 13.88 29.13 44.85
15 22.0 M 11 0 0 0 6.88 7.02 17.54 42.38 55.32
F 3 0 0 0 5.97 5.97 14.40 28.80 47.83
16 22.5 M 6 0 0 0 6.58 6.63 12.67 28.80 48.73
F 10 0 0 0 6.21 6.40 12.40 27.95 47.05
17 22.0 M 8 0 0 0 6.61 6.75 18.60 34.80 55.73
F 5 0 0 0 6.28 6.33 17.43 33.10 53.58
18 23.0 M 10 1 0 0 7.56 7.70 20.65 39.90 62.28
F 4 0 0 0 6.90 6.90 19.05 37.03 57.08
19 21.5 M 5 0 0 0 6.20 6.13 38.75 31.95 51.93
F 11 0 0 0 5.92 6.00 13.08 30.55 47.98
20 22.0 M 6 0 0 0 6.53 6.50 17.93 37.10 59.90
F 7 0 0 0 5.91 5.93 14.03 29.30 47.63


Dose Dam Gest Sex A D C N WT 0 7 14 21
30 21 22.0 M 5 0 0 0 6.08 6.10 13.90 30.78 50.10
F 7 0 0 0 5.73 5.85 13.53 30.58 49.23
22 21.5 M 8 0 0 0 6.05 6.03 14.45 32.33 49.30
F 7 0 0 0 5.67 5.78 13.90 30.83 46.75
23 22.5 M 6 0 0 0 7.43 7.40 18.25 37.55 57.75
F 7 1 0 0 6.70 6.95 16.98 35.50 53.25
24 21.0 M 6 0 0 1 5.83 6.08 17.15 33.75 53.10
F 4 0 0 0 5.38 5.38 15.45 30.10 47.90
25 ---- M -- Dam not ---- ---- ----- ----- -----
F -- impregnated -- ---- ----- ----- -----
26 23.0 M 4 0 0 0 7.48 7.48 18.33 35.43 56.18
F 6 0 0 0 6.50 6.63 17.38 34.43 56.15
27 22.0 M 8 0 0 0 6.26 6.48 16.53 36.25 53.60
F 5 0 0 0 5.76 5.85 15.63 34.60 51.88
28 21.5 M 7 0 0 0 5.80 6.03 10.80 25.40 46.23
F 8 0 0 0 5.45 5.43  8.90 19.68 37.83
29 ---- M -- Dam not ---- ---- ----- ----- -----
F -- impregnated -- ---- ----- ----- -----
30 21.5 M 8 0 0 0 6.03 6.03 13.43 29.28 44.85
F 5 0 0 0 5.48 5.45 12.55 28.43 43.48
31 22.5 M 3 0 0 0 7.30 7.30 16.50 35.47 57.50
F 7 1 0 0 7.23 7.23 13.13 30.68 50.70
32 23.5 M 3 0 0 0 8.20 8.20 18.83 32.80 56.53
F 6 0 0 0 7.92 7.94 17.98 31.98 54.54
33 22.5 M 8 0 0 0 6.69 6.80 16.38 33.85 56.30
F 6 0 0 0 6.43 6.43 15.25 32.08 54.75
34 21.5 M 5 0 0 0 5.62 5.70 14.70 32.48 52.30
F 6 0 0 0 5.32 5.28 13.08 29.88 47.20
35 21.5 M 11 0 0 0 5.26 5.34 11.24 26.18 43.76
F 3 0 0 0 4.97 4.97  9.63 22.77 39.30
36 24.5 M 4 0 0 0 7.13 7.13 17.60 32.20 53.53
F 4 2 1 0 6.53 6.53 16.38 30.98 50.50
37 22.5 M 4 0 0 0 8.35 8.35 16.03 30.00 52.03
F 1 0 0 0 8.30 8.30 17.80 34.00 55.40
38 22.0 M 9 0 0 0 5.99 5.95 14.60 29.78 47.93
F 6 0 0 0 5.78 5.90 15.83 32.50 49.98
39 ---- M -- Dam not ---- ---- ----- ----- -----
F -- impregnated -- ---- ----- ----- -----
40 22.0 M 8 0 0 0 6.53 6.80 17.10 33.55 53.33
F 8 0 0 0 5.39 5.88 14.15 28.20 45.15


Dose Dam Gest Sex A D C N WT 0 7 14 21
100 41 23.0 M 5 1 0 0 6.42 6.43 11.03 24.53 41.00
F 8 0 0 0 5.65 5.90  8.45 21.20 36.75
42 21.5 M 10 0 0 0 5.28 5.40 11.80 27.70 43.80
F 6 0 0 0 5.87 5.88 13.13 29.55 45.48
43 22.5 M 6 0 0 0 6.83 6.93 15.55 30.93 50.15
F 7 1 0 0 6.46 6.83 15.58 30.68 49.15
44 22.0 M 10 0 0 0 6.78 6.88 13.22 29.14 46.68
F 3 0 0 0 6.50 6.50 12.60 26.53 42.80
45 22.0 M 4 0 0 0 6.38 6.38 15.45 32.45 50.78
F 10 0 0 0 5.95 5.95 13.75 29.88 47.63
46 21.5 M 6 0 0 0 5.42 5.58 14.23 30.50 47.80
F 6 0 0 0 5.12 5.10 12.00 26.38 42.40
47 22.0 M 9 0 0 0 5.38 5.50 12.43 25.68 40.83
F 8 0 0 0 4.80 4.95 11.85 25.45 39.80
48 22.5 M 6 0 0 0 7.92 7.80 17.90 35.28 55.65
F 7 0 0 0 7.74 7.60 16.98 33.35 54.23
49 22.5 M 3 1 0 0 6.83 6.83 11.57 28.57 45.70
F 7 2 0 0 6.60 6.63 13.45 32.48 53.03
50 22.5 M 5 3 0 0 5.96 5.95 13.55 29.28 47.20
F 6 3 0 0 5.83 5.88 12.58 28.25 44.93
51 22.0 M 6 0 0 0 6.08 6.08 16.50 33.95 54.78
F 7 0 0 0 5.70 5.68 15.78 33.30 51.75
52 23.0 M 7 0 0 0 6.64 6.53 18.15 36.18 56.95
F 7 0 0 0 6.49 6.37 17.33 34.47 54.00
53 22.5 M 7 0 0 0 6.41 6.40 12.03 31.87 52.07
F 9 0 0 0 6.00 6.10 12.20 29.28 49.08
54 21.5 M 6 0 0 0 5.80 5.90 12.00 26.43 44.55
F 8 0 0 0 5.36 5.40 10.48 22.98 37.23
55 23.0 M 3 0 0 0 6.53 6.53 18.80 36.50 59.60
F 9 2 0 0 6.43 6.50 19.15 36.68 58.23
56 23.0 M 8 1 0 0 6.56 6.90 15.13 32.27 53.47
F 5 0 0 0 6.42 6.53 13.75 29.83 50.48
57 22.0 M 4 0 0 0 6.78 6.78 16.58 30.73 47.83
F 4 0 0 0 6.45 6.45 14.95 30.33 45.15
58 22.5 M 8 0 0 0 7.06 7.00 15.90 31.23 48.65
F 6 0 0 0 6.65 6.68 16.00 32.53 51.45
59 22.0 M 3 0 0 0 5.73 5.73 14.97 28.67 48.67
F 10 0 0 0 5.44 5.52 14.66 29.16 49.40
60 21.5 M 8 0 0 0 5.51 5.58 15.08 32.93 52.83
F 6 0 0 0 5.25 5.18 13.36 30.58 49.23


Dose Dam Gest Sex A D C N WT 0 7 14 21
300 61 22.5 M 4 0 0 1 7.33 7.33 14.55 31.43 49.05
F 3 0 0 0 6.67 6.67 14.09 29.30 46.50
62 22.5 M 10 0 0 0 7.03 7.18 15.40 34.05 55.28
F 7 0 0 0 6.36 6.48 13.65 31.48 50.25
63 ---- M -- Dam was ---- ---- ----- ----- -----
F -- sacrificed -- ---- ----- ----- -----
64 22.0 M 10 0 0 0 6.36 6.48 16.28 33.28 55.33
F 8 0 0 0 6.10 6.23 15.83 33.70 54.10
65 22.5 M 8 0 0 0 6.83 7.17 12.43 29.70 47.47
F 8 0 0 0 6.53 6.60 13.83 32.80 51.38
66 21.5 M 8 0 0 0 7.06 6.95 19.53 38.65 60.53
F 5 0 0 0 6.64 6.70 18.38 37.83 57.75
67 22.0 M 8 0 0 0 5.53 5.64 13.04 28.46 45.64
F 3 0 0 0 5.30 5.30 12.47 27.07 44.80
68 22.0 M 6 0 0 0 5.30 6.28 15.63 31.95 53.38
F 8 0 0 0 5.83 5.63 14.38 30.15 49.53
69 22.0 M 4 0 0 0 5.78 5.78 13.85 25.65 37.03
F 11 0 0 0 5.58 5.68 14.00 27.18 39.90
70 21.5 M 5 0 0 0 6.08 6.00 15.63 33.23 49.90
F 8 0 0 0 5.66 5.68 14.78 31.55 47.63
71 21.5 M 11 0 0 0 5.95 5.88 10.78 26.50 41.44
F 3 1 0 0 5.73 5.73  8.50 20.87 35.03
72 22.5 M 5 0 0 0 7.38 7.43 15.34 30.40 48.20
F 4 0 0 0 7.23 7.23 15.13 29.33 46.88
73 22.5 M 8 0 0 0 6.93 7.13 15.50 32.37 52.00
F 7 0 0 0 6.73 6.83 14.63 31.43 49.93
74 21.5 M 7 0 0 0 5.96 5.98 11.60 28.68 47.70
F 6 1 0 0 5.22 5.38 11.25 28.70 46.63
75 22.0 M 4 0 0 0 7.23 7.23 18.65 34.93 52.33
F 7 0 0 0 6.61 6.63 16.58 32.30 50.65
76 22.0 M 6 0 0 0 6.47 6.55 16.53 32.08 49.13
F 7 0 0 0 6.19 6.10 15.23 32.55 49.33
77 22.5 M 6 0 0 0 7.35 7.30 16.90 36.40 58.80
F 7 0 0 0 7.04 7.08 15.70 34.10 56.38
78 22.5 M 6 0 0 0 6.63 6.67  9.67 23.70 41.37
F 8 0 0 0 6.13 6.23 9.27 23.00 39.33
79 22.5 M 6 0 0 0 5.67 5.83 12.98 29.15 47.55
F 12 0 0 0 5.63 5.38 12.15 26.78 43.05
80 23.5 M 4 0 2 0 5.98 5.98 11.85 25.93 41.05
F 4 0 1 0 5.73 5.73 11.25 25.23 40.30


Dose Dam Gest Sex A D C N WT 0 7 14 21
300+ 81 22.0 M 6 4 0 0 6.88 6.85 18.28 35.93 52.23
F 4 1 0 0 6.38 6.38 16.88 33.98 51.25
82 22.0 M 5 0 0 0 7.18 7.28 18.83 36.80 61.68
F 4 0 0 0 6.80 6.80 16.93 34.08 57.33
83 22.0 M 7 0 0 0 6.56 6.73 16.65 35.50 55.50
F 10 0 0 0 6.29 6.35 16.20 34.40 57.55
84 22.5 M 9 0 0 0 7.10 6.90 15.70 32.75 52.88
F 5 1 0 0 6.88 6.78 16.08 31.68 49.60
85 23.0 M 7 1 0 0 7.33 7.70 20.15 37.43 63.23
F 6 0 0 0 7.45 7.70 20.30 37.55 61.43
86 22.5 M 7 1 0 0 7.19 7.28 13.35 27.40 45.55
F 7 1 0 0 6.90 6.75 13.08 26.63 45.00
87 22.5 M 6 1 0 0 7.37 7.50 18.95 38.15 58.48
F 8 0 0 0 7.14 7.13 18.25 36.90 56.10
88 22.0 M 10 0 0 0 6.88 6.70 17.63 34.98 55.75
F 5 0 0 0 6.24 6.18 16.10 32.75 52.73
89 21.5 M 9 0 0 0 6.71 6.73 15.33 31.85 49.08
F 4 0 0 0 6.48 6.48 14.93 31.28 49.43
90 23.0 M 8 0 0 0 7.54 7.68 14.83 31.18 49.40
F 7 0 0 0 6.83 6.70 14.15 29.65 45.53
91 22.0 M 1 0 0 0 7.20 ---- Data are --- -----
F 3 0 0 0 6.87 ---- missing --- -----
92 22.0 M 6 0 0 0 7.33 7.23 15.93 32.88 52.43
F 6 0 0 0 6.87 6.83 15.40 31.33 51.48
93 22.5 M 9 0 0 0 6.96 6.98 16.48 34.68 54.08
F 6 0 0 0 6.22 6.08 15.10 32.30 51.88
94 ---- M -- Dam not ---- ---- ----- ----- -----
F -- bred ---- ---- ----- ----- -----
95 22.0 M 4 2 0 0 6.28 6.28 14.55 30.23 46.60
F 7 1 0 0 6.01 6.08 13.93 28.98 43.85
96 22.0 M 6 0 0 0 6.62 6.63 16.93 34.05 52.50
F 10 0 0 0 6.32 6.33 16.83 33.63 52.65
97 21.5 M 6 0 0 0 6.40 6.53 15.33 34.80 53.88
F 9 0 0 0 6.08 6.08 14.35 33.08 50.03
98 22.5 M 4 0 0 0 6.95 6.95 14.70 32.53 52.38
F 10 0 0 0 7.00 7.43 17.18 36.15 55.68
99 22.5 M 3 0 0 0 7.87 7.87 16.77 31.23 53.47
F 7 1 0 0 7.57 7.48 16.92 31.28 51.92
100 21.5 M 10 0 0 0 6.39 6.23 15.05 30.85 47.43
F 7 0 0 0 5.93 5.88 14.05 29.10 45.03


Source:

Bradstreet, T.E. (1991) "Some Favorite Data Sets from Early Phases of Drug Research." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 14, 1997 - THS