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This is an example of an Exposure dataset for selected animals from a nonclinical inhalation study in rats. Subjects were randomized to one of three treatment groups with the test article at dose levels of 0.7, 2.1, and 7.1 mg/kg/day and one control group receiving vehicle. The study included 13 weeks of treatment. 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 treatment 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 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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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-222 |
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-221 |
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| Dataset wrap |
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| Rows 1-5: | Each animal had one 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. |
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-221 |
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXROUTE | EXLOT | EXFAST | EXTRTV | EXVAMT | EXVAMTU | EXADJ | EXSTDTC | EXENDTC | EXSTDY | EXENDY | EXDUR |
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| 1 | 12345 | EX | 12345-001 | 1 | CX2345 | 0 | mg/kg/day | AEROSOL | RESPIRATORY (INHALATION) |
| Y | 5% (w/v) of D-Mannitol in deionized water |
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| 2021-06-01 | 2021-09-01 | 1 | 91 | PT60M | | 2 | 12345 | EX | 12345-002 | 2 | CX2345 | 0.7 | mg/kg/day | AEROSOL | RESPIRATORY (INHALATION) | AB789.1 | Y | 5% (w/v) of D-Mannitol in deionized water |
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| 2021-06-01 | 2021-09-01 | 1 | 91 | PT60M | | 3 | 12345 | EX | 12345-003 | 3 | CX2345 | 2.1 | mg/kg/day | AEROSOL | RESPIRATORY (INHALATION) | AB789.1 | Y | 5% (w/v) of D-Mannitol in deionized water |
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| 2021-06-01 | 2021-09-01 | 1 | 91 | PT60M | | 4 | 12345 | EX | 12345-004 | 4 | CX2345 | 7.1 | mg/kg/day | AEROSOL | RESPIRATORY (INHALATION) | AB789.1 | Y | 5% (w/v) of D-Mannitol in deionized water |
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| 2021-06-01 | 2021-08-15 | 1 | 40 | PT60M | | 5 | 12345 | EX | 12345-004 | 5 | CX2345 | 5 | mg/kg/day | AEROSOL | RESPIRATORY (INHALATION) | AB789.1 | Y | 5% (w/v) of D-Mannitol in deionized water |
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| Reduced due to toxicity | 2021-08-15 | 2021-09-01 | 41 | 91 | PT60M |
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