SEND Example.In vivo Multifactorial Study Design

The example depicts a complex multifactorial trial design. The applicant-defined protocol specifies the following information: All subjects are to be screened for 7 days prior to randomization into 3 protocol groups:

Group 1 is a control group of 40 subjects, 20 male and 20 female, dosed with vehicle once per day for 30 days. Of this group, 10 males and 10 females will be fed ad libitum, while the remainder will be subject to a restricted diet. Half of the subjects will be terminated after 30 days, while the other half will be subject to a 14-day recovery period; the subjects selected for recovery will be divided equally among animals fed ad libitum and those subject to restricted feeding (i.e., 5 males and 5 females with ad libitum feeding will move to recovery, and 5 males and 5 females with restricted diet will also move to recovery).
Group 2 is a low-dose group of 40 subjects, 20 male and 20 female, dosed at 5 mg/kg once per day for 30 days. Of this group, 10 males and 10 females will be fed ad libitum, while the remainder will be subject to a restricted diet. Three subjects of each sex and feeding pattern will be subject to blood sampling for the purpose of TK analysis (i.e., 3 males and 3 females from those fed ad libitum and 3 males and 3 females from those receiving a restricted diet)
Group 3 is a high-dose group of 40 subjects, 20 male and 20 female, dosed at 100 mg/kg once per day for 30 days. Of this group, 10 males and 10 females will be fed ad libitum, while the remainder will be subject to a restricted diet. Of those subjects fed ad libitum, 3 males and 3 females will be subject to blood sampling for the purpose of TK analysis and terminated on day 30; 3 males and 3 females (other than those selected for TK analysis) will be subject to a 14-day recovery period, and the remaining subjects will be terminated on day 30. of the subjects given a restricted diet, 6 males and 6 females will be subject to blood sampling for the purpose of TK analysis; half of these subjects will be terminated on day 30 while the others are subject to a 14-day recovery period before termination. The balance of the subjects receiving a restricted diet will be terminated at the end of the dosing period (day 30).

Group Number	Group Label	Dose Level	Number of Animals (Both Sexes Combined)
			Fed Ad Libitum				Restricted Feeding
			Non-toxicokinetic		Toxicokinetic		Non-toxicokinetic		Toxicokinetic
			Nonrecovery	Recovery	Nonrecovery	Recovery	Nonrecovery	Recovery	Nonrecovery	Recovery
1	Group 1, Control	Vehicle Control	10	10	0	0	10	10	0	0
2	Group 2, 5 mg/kg	5 mg/kg/day	14	0	6	0	14	0	6	0
3	Group 3, 100 mg/kg	100 mg/kg/day	8	6	6	0	8	0	6	6

There are no other experimental factors of interest specified in the study design.

Figure. Example Trial 4 Design

Trial Elements

The variety of feeding and TK analysis factors do not affect the TE dataset, which deals only with dosing. The fact that only some of the dosing elements are combined with the recovery element is only captured in the TA dataset.

TOBA-215 - Getting issue details... STATUS

te.xpt

Row	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
1	TDM4	TE	SCRN	Screen	Start of screening period	7 days after start of Element	P7D
2	TDM4	TE	CONTROL	Control	At completion of SCRN Element	30 days after start of Element	P30D
3	TDM4	TE	T5	5 mg/kg Drug A	At completion of SCRN Element	30 days after start of Element	P30D
4	TDM4	TE	T100	100 mg/kg Drug A	At completion of SCRN Element	30 days after start of Element	P30D
5	TDM4	TE	RECO	Recovery	1 day after last dose with product or vehicle control	14 days after start of Element	P14D

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Trial Arms

Despite the complex description in the study protocol, there are only 5 trial arms in this study. All subjects experience a screening element. Based upon the result of randomization, they then receive 1 of 3 different exposure levelsexp; some of the subjects receiving the vehicle control or the high dose are subject to a recovery period post-exposure. This can be depicted as follows.

ta.xpt

Row	STUDYID	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT	TABRANCH	EPOCH
1	TDM4	TA	1	Control	1	SCRN	Screen	Randomized to Group 1	PRE-EXPOSURE
2	TDM4	TA	1	Control	2	CONTROL	Control		EXPOSURE
3	TDM4	TA	1R	Control + Recovery	1	SCRN	Screen	Randomized to Group 1 with Recovery	PRE-EXPOSURE
4	TDM4	TA	1R	Control + Recovery	2	CONTROL	Control		EXPOSURE
5	TDM4	TA	1R	Control + Recovery	3	RECO	Recovery		RECOVERY
6	TDM4	TA	2	Low Dose	1	SCRN	Screen	Randomized to Group 2	PRE-EXPOSURE
7	TDM4	TA	2	Low Dose	2	T5	5 mg/kg Drug A		EXPOSURE
8	TDM4	TA	3	High Dose	1	SCRN	Screen	Randomized to Group 3	PRE-EXPOSURE
9	TDM4	TA	3	High Dose	2	T100	100 mg/kg Drug A		EXPOSURE
10	TDM4	TA	3R	High Dose + Recovery	1	SCRN	Screen	Randomized to Group 3 with Recovery	PRE-EXPOSURE
11	TDM4	TA	3R	High Dose + Recovery	2	T100	100 mg/kg Drug A		EXPOSURE
12	TDM4	TA	3R	High Dose + Recovery	3	RECO	Recovery		RECOVERY

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Trial Sets

In this study there are multiple experimental factors of interest: the dosing level given during the exposure epoch (3 levels), the feeding regimen of the subjects (ad libitum vs. restricted feeding), whether the subjects are to be used for TK analysis, and whether the subjects will be terminated at the end of the dosing period or experience a recovery period. The combination of these factors (3x2x2x2) could lead to up to 24 possible combinations or sets; however, upon careful reading of the description there are 14 sets that will actually be part of the study:

Vehicle Control + Fed Ad Libitum + No Recovery + No TK analysis
Vehicle Control + Restricted Feeding + No Recovery + No TK analysis
Vehicle Control + Fed Ad Libitum + Recovery + No TK analysis
Vehicle Control + Restricted Feeding + Recovery + No TK analysis
Low Dose + Fed Ad Libitum + No Recovery + No TK analysis
Low Dose + Restricted Feeding + No Recovery + No TK analysis
Low Dose + Fed Ad Libitum + No Recovery + TK analysis
Low Dose + Restricted Feeding + No Recovery + TK analysis
High Dose + Fed Ad Libitum + No Recovery + No TK analysis
High Dose + Fed Ad Libitum + Recovery + No TK analysis
High Dose + Fed Ad Libitum + No Recovery + TK analysis
High Dose + Restricted Feeding + No Recovery + TK analysis
High Dose + Restricted Feeding + Recovery + TK analysis
High Dose + Restricted Feeding + No Recovery + No TK analysis

This can be represented in the TS domain as follows. The applicant is providing the following information for each set: arm code, applicant-defined group code, group label, dose level and units, control type, feeding regimen, toxicokinetic description, and planned number of subjects (not broken out by sex).

tx.xpt

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	1	ARMCD	Arm Code	1
2	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	2	SPGRPCD	Applicant-Defined Group Code	1
3	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	3	GRPLBL	Group Label	Group 1, Control
4	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	4	TRTDOS	Dose Level	0
5	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	5	TRTDOSU	Dose Units	mg/kg/day
6	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	6	TCNTRL	Control Type	VEHICLE CONTROL
7	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	7	FEEDREG	Feeding Regimen	Ad Libitum
8	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	8	TKDESC	Toxicokinetic Description	NON-TK
9	TDM4	TX	1F1	Control Group, Control Article Name once daily, Fed Ad Libitum	9	SPLANSUB	Planned Number of Subjects	10
10	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	10	ARMCD	Arm Code	1R
11	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	11	SPGRPCD	Applicant-Defined Group Code	1
12	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	12	GRPLBL	Group Label	Group 1, Control
13	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	13	TRTDOS	Dose Level	0
14	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	14	TRTDOSU	Dose Units	mg/kg/day
15	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	15	TCNTRL	Control Type	VEHICLE CONTROL
16	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	16	FEEDREG	Feeding Regimen	Ad Libitum
17	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	17	TKDESC	Toxicokinetic Description	NON-TK
18	TDM4	TX	1F1R	Control Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals	18	SPLANSUB	Planned Number of Subjects	10
19	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	19	ARMCD	Arm Code	1
20	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	20	SPGRPCD	Applicant-Defined Group Code	1
21	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	21	GRPLBL	Group Label	Group 1, Control
22	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	22	TRTDOS	Dose Level	0
23	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	23	TRTDOSU	Dose Units	mg/kg/day
24	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	24	TCNTRL	Control Type	VEHICLE CONTROL
25	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	25	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
26	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	26	TKDESC	Toxicokinetic Description	NON-TK
27	TDM4	TX	1F2	Control Group, Control Article Name once daily, Restricted Diet	27	SPLANSUB	Planned Number of Subjects	10
28	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	28	ARMCD	Arm Code	1R
29	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	29	SPGRPCD	Applicant-Defined Group Code	1
30	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	30	GRPLBL	Group Label	Group 1, Control
31	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	31	TRTDOS	Dose Level	0
32	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	32	TRTDOSU	Dose Units	mg/kg/day
33	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	33	TCNTRL	Control Type	VEHICLE CONTROL
34	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	34	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
35	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	35	TKDESC	Toxicokinetic Description	NON-TK
36	TDM4	TX	1F2R	Control Group, Control Article Name once daily, Restricted Diet, Recovery animals	36	SPLANSUB	Planned Number of Subjects	10
37	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	37	ARMCD	Arm Code	2
38	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	38	SPGRPCD	Applicant-Defined Group Code	2
39	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	39	GRPLBL	Group Label	Group 2, 5 mg/kg/day
40	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	40	TRTDOS	Dose Level	5
41	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	41	TRTDOSU	Dose Units	mg/kg/day
42	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	42	FEEDREG	Feeding Regimen	Ad Libitum
43	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	43	TKDESC	Toxicokinetic Description	NON-TK
44	TDM4	TX	2F1	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum	44	SPLANSUB	Planned Number of Subjects	14
45	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	45	ARMCD	Arm Code	2
46	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	46	SPGRPCD	Applicant-Defined Group Code	2
47	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	47	GRPLBL	Group Label	Group 2, 5 mg/kg/day
48	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	48	TRTDOS	Dose Level	5
49	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	49	TRTDOSU	Dose Units	mg/kg/day
50	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	50	FEEDREG	Feeding Regimen	Ad Libitum
51	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	51	TKDESC	Toxicokinetic Description	TK
52	TDM4	TX	2F1T	Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	52	SPLANSUB	Planned Number of Subjects	6
53	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	53	ARMCD	Arm Code	2
54	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	54	SPGRPCD	Applicant-Defined Group Code	2
55	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	55	GRPLBL	Group Label	Group 2, 5 mg/kg/day
56	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	56	TRTDOS	Dose Level	5
57	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	57	TRTDOSU	Dose Units	mg/kg/day
58	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	58	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
59	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	59	TKDESC	Toxicokinetic Description	NON-TK
60	TDM4	TX	2F2	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet	60	SPLANSUB	Planned Number of Subjects	14
61	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	61	ARMCD	Arm Code	2
62	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	62	SPGRPCD	Applicant-Defined Group Code	2
63	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	63	GRPLBL	Group Label	Group 2, 5 mg/kg/day
64	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	64	TRTDOS	Dose Level	5
65	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	65	TRTDOSU	Dose Units	mg/kg/day
66	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	66	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
67	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	67	TKDESC	Toxicokinetic Description	TK
68	TDM4	TX	2F2T	Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals	68	SPLANSUB	Planned Number of Subjects	6
69	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	69	ARMCD	Arm Code	3
70	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	70	SPGRPCD	Applicant-Defined Group Code	3
71	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	71	GRPLBL	Group Label	Group 3, 100 mg/kg/day
72	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	72	TRTDOS	Dose Level	100
73	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	73	TRTDOSU	Dose Units	mg/kg/day
74	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	74	FEEDREG	Feeding Regimen	Ad Libitum
75	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	75	TKDESC	Toxicokinetic Description	NON-TK
76	TDM4	TX	3F1	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum	76	SPLANSUB	Planned Number of Subjects	8
77	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	77	ARMCD	Arm Code	3R
78	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	78	SPGRPCD	Applicant-Defined Group Code	3
79	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	79	GRPLBL	Group Label	Group 3, 100 mg/kg/day
80	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	80	TRTDOS	Dose Level	100
81	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	81	TRTDOSU	Dose Units	mg/kg/day
82	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	82	FEEDREG	Feeding Regimen	Ad Libitum
83	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	83	TKDESC	Toxicokinetic Description	NON-TK
84	TDM4	TX	3F1R	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals	84	SPLANSUB	Planned Number of Subjects	6
85	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	85	ARMCD	Arm Code	3
86	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	86	SPGRPCD	Applicant-Defined Group Code	3
87	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	87	GRPLBL	Group Label	Group 3, 100 mg/kg/day
88	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	88	TRTDOS	Dose Level	100
89	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	89	TRTDOSU	Dose Units	mg/kg/day
90	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	90	FEEDREG	Feeding Regimen	Ad Libitum
91	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	91	TKDESC	Toxicokinetic Description	TK
92	TDM4	TX	3F1T	High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals	92	SPLANSUB	Planned Number of Subjects	6
93	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	93	ARMCD	Arm Code	3
94	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	94	SPGRPCD	Applicant-Defined Group Code	3
95	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	95	GRPLBL	Group Label	Group 3, 100 mg/kg/day
96	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	96	TRTDOS	Dose Level	100
97	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	97	TRTDOSU	Dose Units	mg/kg/day
98	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	98	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
99	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	99	TKDESC	Toxicokinetic Description	NON-TK
100	TDM4	TX	3F2	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet	100	SPLANSUB	Planned Number of Subjects	8
101	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	101	ARMCD	Arm Code	3
102	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	102	SPGRPCD	Applicant-Defined Group Code	3
103	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	103	GRPLBL	Group Label	Group 3, 100 mg/kg/day
104	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	104	TRTDOS	Dose Level	100
105	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	105	TRTDOSU	Dose Units	mg/kg/day
106	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	106	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
107	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	107	TKDESC	Toxicokinetic Description	TK
108	TDM4	TX	3F2T	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals	108	SPLANSUB	Planned Number of Subjects	6
109	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	109	ARMCD	Arm Code	3R
110	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	110	SPGRPCD	Applicant-Defined Group Code	3
111	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	111	GRPLBL	Group Label	Group 3, 100 mg/kg/day
112	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	112	TRTDOS	Dose Level	100
113	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	113	TRTDOSU	Dose Units	mg/kg/day
114	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	114	FEEDREG	Feeding Regimen	Restricted Diet (50g/animal/day)
115	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	115	TKDESC	Toxicokinetic Description	TK
116	TDM4	TX	3F2TR	High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals	116	SPLANSUB	Planned Number of Subjects	6

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SEND Example.In vivo Multifactorial Study Design