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There are no other experimental factors of interest specified in the study design. In this case the design consists of 3 trial arms, depicted in the following figure.

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	SENDIG:Figure. Example Trial 2 DesignSENDIG:
	Figure. Example Trial 2 Design

Trial Elements

In this study, treatment dosing started on one date and the necropsy is scheduled, for an individual animal, after 28 to 30 days of treatmentdosing. The necropsy for a subset of animals per treatment exposure group per day will be staggered over a 3-day period.

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Name	te

Dataset2

Row	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
1	TDM2	TE	SCRN	Screen	Start of PretreatmentPre-exposure	1 week after start of Element	P7D
2	TDM2	TE	TRT01	Vehicle Control	First day of dosing with vehicle control	Date of necropsy: 28 to 30 days after start of Element
3	TDM2	TE	TRT02	100 mg/kg Drug A, once daily	First day of dosing with 100 mg/kg Drug A	Date of necropsy: 28 to 30 days after start of Element
4	TDM2	TE	TRT03	500 mg/kg Drug A, once daily	First day of dosing with 500 mg/kg Drug A	Date of necropsy: 28 to 30 days after start of Element

Trial Arms

There are three 3 trial arms in this study. The fact that some subjects are being selected for blood sampling is an experimental factor that is separate from the treatment being dosing being received; this is described in the TS example.

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Name	ta

Dataset2

Row	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
1	TDM2	TA	1	Control	1	SCRN	Screen	Randomized to Group 1	PRE-TREATMENTEXPOSURE
2	TDM2	TA	1	Control	2	TRT01	Vehicle Control		TREATMENTEXPOSURE
3	TDM2	TA	2	100 mg/kg	1	SCRN	Screen	Randomized to Group 2	PRE-TREATMENTEXPOSURE
4	TDM2	TA	2	100 mg/kg	2	TRT02	100 mg/kg Drug A		TREATMENTEXPOSURE
5	TDM2	TA	3	500 mg/kg	1	SCRN	Screen	Randomized to Group 3	PRE-TREATMENTEXPOSURE
6	TDM2	TA	3	500 mg/kg	2	TRT03	500 mg/kg Drug A		TREATMENTEXPOSURE

Trial Sets

Assuming that the protocol also specifies that subjects with blood sampling for TK analysis are experimentally distinct, the factors of interest are the treatment levels dosing levels and whether the subject is sampled for TK analysis; this leads to 6 trial sets.

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