This is an example of an EX dataset for selected animals; subjects were randomized to 1 of 4 product exposure groups. The animals were group housed, so exposure has been derived for each animal. The test article was administered in the diet for 13 weeks at concentrations of 0 ppm, 300 ppm, 750 ppm, and 1500 ppm. The administered dose was calculated based on food consumption and body weight, using the following formula below:
Exposure = [ Dietary concentration (mg/kg) × Food consumption (g/rat/day) ] / Body weight (g) |
Rows 1-3: | Subject 12345001 received test article PHJU during weeks 1, 2, and 3. | Row 1: | EXLOT shows the dietary concentration for week 1 dosing using only lot ABC1. | Row 2: | EXLOT shows that 2 lots of PHJU were mixed into 1 dietary concentration for week 2 dosing; therefore, EXLOT is concatenated as ABC1;ABC2. | Row 3: | EXLOT shows the dietary concentration for week 3 dosing, using only lot ABC2. | Rows 4-6: | EXLOT shows lot DEF1 was used for each dietary concentration of PHJU given to subject 12345025 during weeks 1-3. | |
Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRM | EXDOSFRQ | EXROUTE | EXLOT | EXTRTV | EXSTDTC | EXENDTC | EXSTDY | EXENDY |
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1 | 12345 | EX | 12345001 | 1 | PHJU | 26.91 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | ABC1 | FEED | 2007-06-07T07:30 | 2007-06-13T07:30 | 1 | 7 | 2 | 12345 | EX | 12345001 | 2 | PHJU | 23.43 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | ABC1;ABC2 | FEED | 2007-06-13T7:30 | 2007-06-20 T7:30 | 7 | 14 | 3 | 12345 | EX | 12345001 | 3 | PHJU | 20.63 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | ABC2 | FEED | 2007-06-20T7:30 | 2007-06-27T7:30 | 14 | 21 | 4 | 12345 | EX | 12345025 | 4 | PHJU | 53.52 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | DEF1 | FEED | 2007-06-07T7:30 | 2007-06-13T7:30 | 1 | 7 | 5 | 12345 | EX | 12345025 | 5 | PHJU | 46.87 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | DEF1 | FEED | 2007-06-13T7:30 | 2007-06-20T7:30 | 7 | 14 | 6 | 12345 | EX | 12345025 | 6 | PHJU | 43.53 | mg/kg/day | POWDER | AD LIBITUM | DIETARY | DEF1 | FEED | 2007-06-20T7:30 | 2007-06-27T7:30 | 17 | 21 | |
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