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This is an example of an EX dataset for selected animals; subjects were randomized to 1 of 4 treatment 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)
ex.xpt
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.
ex.xpt
ex.xpt
Row STUDYID DOMAIN USUBJID EXSEQ EXTRT EXDOSE EXDOSU EXDOSFRM EXDOSFRQ EXROUTE EXLOT EXTRTV EXSTDTC EXENDTC EXSTDY EXENDY 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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