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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)


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

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXDOSFRMEXDOSFRQEXROUTEEXLOTEXTRTVEXSTDTCEXENDTCEXSTDYEXENDY
112345EX123450011PHJU26.91mg/kg/dayPOWDERAD LIBITUMDIETARYABC1FEED2007-06-07T07:302007-06-13T07:3017
212345EX123450012PHJU23.43mg/kg/dayPOWDERAD LIBITUMDIETARYABC1;ABC2FEED2007-06-13T7:302007-06-20 T7:30714
312345EX123450013PHJU20.63mg/kg/dayPOWDERAD LIBITUMDIETARYABC2FEED2007-06-20T7:302007-06-27T7:301421
412345EX123450254PHJU53.52mg/kg/dayPOWDERAD LIBITUMDIETARYDEF1FEED2007-06-07T7:302007-06-13T7:3017
512345EX123450255PHJU46.87mg/kg/dayPOWDERAD LIBITUMDIETARYDEF1FEED2007-06-13T7:302007-06-20T7:30714
612345EX123450256PHJU43.53mg/kg/dayPOWDERAD LIBITUMDIETARYDEF1FEED2007-06-20T7:302007-06-27T7:301721
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