Exposure (EX)

Example: Inhalation Study

This is an example of an EX dataset for selected animals from a nonclinical inhalation study in rats. Subjects were randomized to 1 of 4 dose groups with the test article at dose levels of 0.7, 2.1, and 7.1 mg/kg/day and 1 control group receiving vehicle. The study included 13 weeks of dosing. 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 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 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. TOBA-222 - Getting issue details... STATUS TOBA-221 - Getting issue details... STATUS

Rows 1-5:	Each animal had 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.

ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXROUTE	EXLOT	EXFAST	EXTRTV	EXADJ	EXSTDTC	EXENDTC	EXSTDY	EXENDY	EXDUR
1	12345	EX	12345-001	1	CX2345	0	mg/kg/day	AEROSOL	RESPIRATORY (INHALATION)		Y	5% (w/v) of D-Mannitol in deionized water		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		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		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		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	Reduced due to toxicity	2021-08-15	2021-09-01	41	91	PT60M

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example: Oral Dosing Reported with 1 Record for Multiple Days of Dosing

This is an example of an EX dataset for selected animals from a typical nonclinical study. In this example, subjects were randomized to 1 of 4 dose groups: the test article at dose levels of 20, 40, and 100 mg/kg/day (single daily administration), and 1 control. The study included 13 weeks of dosing. However, due to severe clinical signs, the dose level for subject 12345004 was reduced from 100 to 75 during week 6. The other subjects remained on the same dose level throughout the study. With respect to timing of doses, the applicant only collected the start and stop dates of uninterrupted periods of dosing.

ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EXLOT	EXTRTV	EXADJ	EXSTDTC	EXENDTC	EXSTDY	EXENDY
1	12345	EX	12345001	1	CX2345	0	mg/kg	SUSPENSION	QD	ORAL GAVAGE		CMC		2007-01-08	2007-04-08	1	91
2	12345	EX	12345002	2	CX2345	20	mg/kg	SUSPENSION	QD	ORAL GAVAGE	AB789.1	CMC		2007-01-08	2007-04-08	1	91
3	12345	EX	12345003	3	CX2345	40	mg/kg	SUSPENSION	QD	ORAL GAVAGE	AB789.1	CMC		2007-01-08	2007-04-08	1	91
4	12345	EX	12345004	4	CX2345	100	mg/kg	SUSPENSION	QD	ORAL GAVAGE	AB789.1	CMC		2007-01-08	2007-02-16	1	40
5	12345	EX	12345004	5	CX2345	75	mg/kg	SUSPENSION	QD	ORAL GAVAGE	AB789.1	CMC	Reduced due to toxicity	2007-02-17	2007-04-09	41	91

$warningHtml

Example: Oral Gavage - 1 Record per Dosing with Multiple Treatments

This is an example of an EX dataset for selected animals from a toxicology study using 2 product exposures and a vehicle control with once-weekly oral administration. Subjects were randomized to 1 of 5 groups. In this example, results are shown for 5 animals, 1 in each group, with 1 record each for the first 2 weeks. For the control group, the EXTRT is listed as the 2 product substances, concatenated with a pipe and zero dose.

ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXROUTE	EXLOT	EXTRTV	EXVAMT	EXVAMTU	EXSTDTC	EXSTDY
1	12345	EX	12345001	1	RP187\|RP188	0	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE		Saline	5	mL	2013-08-20	1
2	12345	EX	12345002	2	RP187	10	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.1308	Saline	5	mL	2013-08-20	1
3	12345	EX	12345003	3	RP187	100	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.1308	Saline	5	mL	2013-08-20	1
4	12345	EX	12345004	4	RP188	10	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.2212	Saline	5	mL	2013-08-20	1
5	12345	EX	12345005	5	RP188	100	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.2212	Saline	5	mL	2013-08-20	1
6	12345	EX	12345001	6	RP187\|RP188	0	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE		Saline	5	mL	2013-08-27	8
7	12345	EX	12345002	7	RP187	10	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.1308	Saline	5	mL	2013-08-27	8
8	12345	EX	12345003	8	RP187	100	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.1308	Saline	5	mL	2013-08-27	8
9	12345	EX	12345004	9	RP188	10	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.2212	Saline	5	mL	2013-08-27	8
10	12345	EX	12345005	10	RP188	100	mg/kg	SOLUTION	1 TIME PER WEEK	ORAL GAVAGE	Ta.2212	Saline	5	mL	2013-08-27	8

$warningHtml

« Disposition (DS)

Body Weight (BW) »

Page tree

Exposure (EX)