Favorite Datasets from Early Phases of Drug Research
Oral Toxicity Study in Dogs
Part 2 - Table 3
Sixteen male and 16 female dogs were assigned randomly to treatment with either a Vehicle Control or to one of three graded doses (8, 25, 75 mg/kg) of an investigational compound. Four dogs of each sex were assigned to each treatment group. Oral dosing by gavage was performed once daily, seven days a week, for a period of 12 consecutive weeks. Prior to treatment and again at Weeks 4, 8, and 12, blood samples were collected from the jugular vein of each animal following overnight starvation. Alkaline phosphatase levels (U/L) were assayed from the blood samples.
- Is there a dose response in alkaline phosphatase levels?
(Should dose response be assessed by all pairwise contrasts? All doses versus the Vehicle Control? Using regression? "Stepping up" or "stepping down"?)
- How will the repeated measures on each animal be handled?
- Should sexes be combined or evaluated separately?
Return to top
Return to Favorite Datasets Index
| Part 2 - Table 3 |
| Oral Toxicity in Dogs |
| Alkaline Phosphatase Levels (U/L) |
| Males |
|
|
Females |
| Dose | | Week | |
| Dose | | Week |
| (mg/kg) | Dog | 0 | 4 | 8 | 12 | |
| (mg/kg) | Dog | 0 | 4 | 8 | 12 |
| 0 |
101 |
169 |
136 |
125 |
122 |
|
|
0 |
151 |
125 |
105 |
92 |
86 |
|
102 |
291 |
282 |
218 |
154 |
|
|
|
152 |
138 |
94 |
81 |
72 |
|
103 |
158 |
128 |
104 |
91 |
|
|
|
153 |
113 |
91 |
81 |
72 |
|
104 |
122 |
113 |
91 |
82 |
|
|
|
154 |
137 |
94 |
79 |
75 |
| 8 |
201 |
203 |
171 |
141 |
109 |
|
|
8 |
251 |
170 |
150 |
125 |
121 |
|
202 |
178 |
154 |
127 |
114 |
|
|
|
252 |
139 |
127 |
103 |
94 |
|
203 |
141 |
104 |
90 |
80 |
|
|
|
253 |
131 |
152 |
112 |
99 |
|
204 |
181 |
143 |
120 |
125 |
|
|
|
254 |
125 |
105 |
91 |
82 |
| 25 |
301 |
101 |
80 |
78 |
83 |
|
|
25 |
351 |
113 |
101 |
89 |
122 |
|
302 |
199 |
149 |
147 |
142 |
|
|
|
352 |
150 |
113 |
105 |
90 |
|
303 |
141 |
138 |
118 |
108 |
|
|
|
353 |
155 |
161 |
134 |
116 |
|
304 |
149 |
131 |
133 |
134 |
|
|
|
354 |
133 |
197 |
218 |
159 |
| 75 |
401 |
135 |
218 |
204 |
226 |
|
|
75 |
452 |
113 |
148 |
122 |
143 |
|
402 |
153 |
164 |
148 |
146 |
|
|
|
453 |
102 |
191 |
172 |
162 |
|
403 |
147 |
192 |
205 |
167 |
|
|
|
454 |
128 |
226 |
261 |
279 |
|
404 |
157 |
168 |
168 |
165 |
|
|
|
455 |
91 |
173 |
156 |
202 |
Source:
Bradstreet, T.E. (1992) "Favorite Data Sets from Early Phases of
Drug Research - Part 2."
Proceedings of the Section on Statistical Education of
the American Statistical Association.
Return to top
Return to Favorite Datasets Index