This is an example of an EX dataset for selected animals from a nonclinical inhalation study in rats. Subjects were randomized to 1 of 4 dose groups with the test article at dose levels of 0.7, 2.1, and 7.1 mg/kg/day and 1 control group receiving vehicle. The study included 13 weeks of dosing. However, due to severe clinical signs, the dose level for group 4 animals was reduced from 7.1 to 5 during week 6. The other groups remained on the same dose level throughout the study. The animals were placed in inhalation chambers each day for 60 minutes over the 13 weeks period. Prior to first dose and during the study exposure levels were measured by placing a filter for a given time or a set amount of air passing in a port hole in the inhalation chamber. However, the EXDOSE in this inhalation study contain the planned dose level.TOBA-222
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Getting issue details...STATUSTOBA-221
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Getting issue details...STATUS
Rows 1-5:
Each animal had 1 record for each exposure period. Volume delivered per porthole is not available so EXVAMT/EXVAMTU variables are not populated. EXDUR was populated with the time the animals are exposed per exposure incident.
Rows 4-5:
Animal 12345-004 had dose reduced from7.1 to 5 mgon day 41 due to clinical signs as explained in the EXADJ variable.