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Excerpt
hiddentrue

Inhalation studies 

This is an example of an Exposure EX dataset for selected animals from a nonclinical inhalation study in rats. Subjects were randomized to one 1 of three treatment 4 dose groups with the test article at dose levels of 0.7, 2.1, and 7.1 mg/kg/day and one 1 control group receiving vehicle. The study included 13 weeks of treatmentdosing. However, due to severe clinical signs, the dose level for group 4 animals was reduced from 7.1 to 5 during Week week 6. The other groups remained on the same treatment 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 are 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.

Jira
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serverIssue Tracker (JIRA)
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Jira
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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-221

Dataset wrap
Nameex
Rowcaps
Rows 1-5:Each animal had one 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 from 7.1 to 5 mg on day 41 due to clinical signs as explained in the EXADJ variable.
Dataset2
RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXDOSFRMEXROUTEEXLOTEXFASTEXTRTVEXVAMTEXVAMTUEXADJEXSTDTCEXENDTCEXSTDYEXENDYEXDUR
112345EX12345-0011CX23450mg/kg/dayAEROSOLRESPIRATORY (INHALATION)
Y5% (w/v) of D-Mannitol in deionized water


2021-06-012021-09-01191PT60M
212345EX12345-0022CX23450.7mg/kg/dayAEROSOLRESPIRATORY (INHALATION)AB789.1Y5% (w/v) of D-Mannitol in deionized water


2021-06-012021-09-01191PT60M
312345EX12345-0033CX23452.1mg/kg/dayAEROSOLRESPIRATORY (INHALATION)AB789.1Y5% (w/v) of D-Mannitol in deionized water


2021-06-012021-09-01191PT60M
412345EX12345-0044CX23457.1mg/kg/dayAEROSOLRESPIRATORY (INHALATION)AB789.1Y5% (w/v) of D-Mannitol in deionized water


2021-06-012021-08-15140PT60M
512345EX12345-0045CX23455mg/kg/dayAEROSOLRESPIRATORY (INHALATION)AB789.1Y5% (w/v) of D-Mannitol in deionized water

Reduced due to toxicity2021-08-152021-09-014191PT60M