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. 2017 Nov 28;13:359. doi: 10.1186/s12917-017-1269-z

Table 1.

Safety variables recorded and samples collected during the in-life phase

Variables Study daysa
Clinical observations General observations twice daily
Cageside observations once daily
Observations 1 h ± 15 min postdose
Detailed observations (Days 7, 10, 13, 21, 28, 34, 41, 44, 47, 55, 62, 69, 75, 78, 81 and 89) 1 h ± 15 min postdose (on dosing days)
Body weight Days 1, 8, 11, 14, 21, 28, 35, 42, 45, 48, 55, 62, 69, 76, 79, 82, 88 and 89
Food consumption Daily
Physical and neurological examinations Days 20, 34, 54, 68 and 88
Injection sites scoring Days of injection (predose and 7 to 8 h postdose) and at 24, 48, and 72 h (±1 h) following each injection
Ophthalmologic examination Day 88
Electrocardiographic examination 1 h ± 15 min postdose on Days 20 and 88
Buccal mucosal bleed times Days 20 and 88
Clinical pathology Days 21, 55 and 89
Bioanalytical collection Dose cycle 1:
On days 1 and 14, samples were collected predose and 1 and 5 h postdose
On days 6, 8 and 11, samples were collected 1 and 5 h postdose
Dose cycle 3:
On days 69 and 82, samples were collected predose and 1 and 5 h postdose
On days 74, 76 and 79, samples were collected 1 and 5 h postdose

aDosing phase length was 88 days and necropsies were performed at study termination at Day 89