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 LabelDose LevelNumber of Animals (Both Sexes Combined)
Fed Ad LibitumRestricted Feeding
Non-toxicokineticToxicokineticNon-toxicokineticToxicokinetic
NonrecoveryRecoveryNonrecoveryRecoveryNonrecoveryRecoveryNonrecoveryRecovery
1Group 1, ControlVehicle Control101000101000
2Group 2, 5 mg/kg5 mg/kg/day1406014060
3Group 3, 100 mg/kg100 mg/kg/day86608066

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

te.xpt

RowSTUDYIDDOMAINETCDELEMENTTESTRLTEENRLTEDUR
1TDM4TESCRNScreenStart of screening period7 days after start of ElementP7D
2TDM4TECONTROLControlAt completion of SCRN Element30 days after start of ElementP30D
3TDM4TET55 mg/kg Drug AAt completion of SCRN Element30 days after start of ElementP30D
4TDM4TET100100 mg/kg Drug AAt completion of SCRN Element30 days after start of ElementP30D
5TDM4TERECORecovery1 day after last dose with product or vehicle control14 days after start of ElementP14D
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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

ta.xpt

RowSTUDYIDDOMAINARMCDARMTAETORDETCDELEMENTTABRANCHEPOCH
1TDM4TA1Control1SCRNScreenRandomized to Group 1PRE-EXPOSURE
2TDM4TA1Control2CONTROLControl
EXPOSURE
3TDM4TA1RControl + Recovery1SCRNScreenRandomized to Group 1 with RecoveryPRE-EXPOSURE
4TDM4TA1RControl + Recovery2CONTROLControl
EXPOSURE
5TDM4TA1RControl + Recovery3RECORecovery
RECOVERY
6TDM4TA2Low Dose1SCRNScreenRandomized to Group 2PRE-EXPOSURE
7TDM4TA2Low Dose2T55 mg/kg Drug A
EXPOSURE
8TDM4TA3High Dose1SCRNScreenRandomized to Group 3PRE-EXPOSURE
9TDM4TA3High Dose2T100100 mg/kg Drug A
EXPOSURE
10TDM4TA3RHigh Dose + Recovery1SCRNScreenRandomized to Group 3 with RecoveryPRE-EXPOSURE
11TDM4TA3RHigh Dose + Recovery2T100100 mg/kg Drug A
EXPOSURE
12TDM4TA3RHigh Dose + Recovery3RECORecovery
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:

  1. Vehicle Control + Fed Ad Libitum + No Recovery + No TK analysis
  2. Vehicle Control + Restricted Feeding + No Recovery + No TK analysis
  3. Vehicle Control + Fed Ad Libitum + Recovery + No TK analysis
  4. Vehicle Control + Restricted Feeding + Recovery + No TK analysis
  5. Low Dose + Fed Ad Libitum + No Recovery + No TK analysis
  6. Low Dose + Restricted Feeding + No Recovery + No TK analysis
  7. Low Dose + Fed Ad Libitum + No Recovery + TK analysis
  8. Low Dose + Restricted Feeding + No Recovery + TK analysis
  9. High Dose + Fed Ad Libitum + No Recovery + No TK analysis
  10. High Dose + Fed Ad Libitum + Recovery + No TK analysis
  11. High Dose + Fed Ad Libitum + No Recovery + TK analysis
  12. High Dose + Restricted Feeding + No Recovery + TK analysis
  13. High Dose + Restricted Feeding + Recovery + TK analysis
  14. 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

tx.xpt

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum1ARMCDArm Code1
2TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum2SPGRPCDApplicant-Defined Group Code1
3TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum3GRPLBLGroup LabelGroup 1, Control
4TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum4TRTDOSDose Level0
5TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum5TRTDOSUDose Unitsmg/kg/day
6TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum6TCNTRLControl TypeVEHICLE CONTROL
7TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum7FEEDREGFeeding RegimenAd Libitum
8TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum8TKDESCToxicokinetic DescriptionNON-TK
9TDM4TX1F1Control Group, Control Article Name once daily, Fed Ad Libitum9SPLANSUBPlanned Number of Subjects10
10TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals10ARMCDArm Code1R
11TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals11SPGRPCDApplicant-Defined Group Code1
12TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals12GRPLBLGroup LabelGroup 1, Control
13TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals13TRTDOSDose Level0
14TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals14TRTDOSUDose Unitsmg/kg/day
15TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals15TCNTRLControl TypeVEHICLE CONTROL
16TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals16FEEDREGFeeding RegimenAd Libitum
17TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals17TKDESCToxicokinetic DescriptionNON-TK
18TDM4TX1F1RControl Group, Control Article Name once daily, Fed Ad Libitum, Recovery animals18SPLANSUBPlanned Number of Subjects10
19TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet19ARMCDArm Code1
20TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet20SPGRPCDApplicant-Defined Group Code1
21TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet21GRPLBLGroup LabelGroup 1, Control
22TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet22TRTDOSDose Level0
23TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet23TRTDOSUDose Unitsmg/kg/day
24TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet24TCNTRLControl TypeVEHICLE CONTROL
25TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet25FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
26TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet26TKDESCToxicokinetic DescriptionNON-TK
27TDM4TX1F2Control Group, Control Article Name once daily, Restricted Diet27SPLANSUBPlanned Number of Subjects10
28TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals28ARMCDArm Code1R
29TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals29SPGRPCDApplicant-Defined Group Code1
30TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals30GRPLBLGroup LabelGroup 1, Control
31TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals31TRTDOSDose Level0
32TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals32TRTDOSUDose Unitsmg/kg/day
33TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals33TCNTRLControl TypeVEHICLE CONTROL
34TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals34FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
35TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals35TKDESCToxicokinetic DescriptionNON-TK
36TDM4TX1F2RControl Group, Control Article Name once daily, Restricted Diet, Recovery animals36SPLANSUBPlanned Number of Subjects10
37TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum37ARMCDArm Code2
38TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum38SPGRPCDApplicant-Defined Group Code2
39TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum39GRPLBLGroup LabelGroup 2, 5 mg/kg/day
40TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum40TRTDOSDose Level5
41TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum41TRTDOSUDose Unitsmg/kg/day
42TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum42FEEDREGFeeding RegimenAd Libitum
43TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum43TKDESCToxicokinetic DescriptionNON-TK
44TDM4TX2F1Low-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum44SPLANSUBPlanned Number of Subjects14
45TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals45ARMCDArm Code2
46TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals46SPGRPCDApplicant-Defined Group Code2
47TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals47GRPLBLGroup LabelGroup 2, 5 mg/kg/day
48TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals48TRTDOSDose Level5
49TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals49TRTDOSUDose Unitsmg/kg/day
50TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals50FEEDREGFeeding RegimenAd Libitum
51TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals51TKDESCToxicokinetic DescriptionTK
52TDM4TX2F1TLow-Dose Group, 5 mg/kg Compound A once daily, Fed Ad Libitum, TK animals52SPLANSUBPlanned Number of Subjects6
53TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet53ARMCDArm Code2
54TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet54SPGRPCDApplicant-Defined Group Code2
55TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet55GRPLBLGroup LabelGroup 2, 5 mg/kg/day
56TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet56TRTDOSDose Level5
57TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet57TRTDOSUDose Unitsmg/kg/day
58TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet58FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
59TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet59TKDESCToxicokinetic DescriptionNON-TK
60TDM4TX2F2Low-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet60SPLANSUBPlanned Number of Subjects14
61TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals61ARMCDArm Code2
62TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals62SPGRPCDApplicant-Defined Group Code2
63TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals63GRPLBLGroup LabelGroup 2, 5 mg/kg/day
64TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals64TRTDOSDose Level5
65TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals65TRTDOSUDose Unitsmg/kg/day
66TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals66FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
67TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals67TKDESCToxicokinetic DescriptionTK
68TDM4TX2F2TLow-Dose Group, 5 mg/kg Compound A once daily, Restricted Diet, TK animals68SPLANSUBPlanned Number of Subjects6
69TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum69ARMCDArm Code3
70TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum70SPGRPCDApplicant-Defined Group Code3
71TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum71GRPLBLGroup LabelGroup 3, 100 mg/kg/day
72TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum72TRTDOSDose Level100
73TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum73TRTDOSUDose Unitsmg/kg/day
74TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum74FEEDREGFeeding RegimenAd Libitum
75TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum75TKDESCToxicokinetic DescriptionNON-TK
76TDM4TX3F1High-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum76SPLANSUBPlanned Number of Subjects8
77TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals77ARMCDArm Code3R
78TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals78SPGRPCDApplicant-Defined Group Code3
79TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals79GRPLBLGroup LabelGroup 3, 100 mg/kg/day
80TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals80TRTDOSDose Level100
81TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals81TRTDOSUDose Unitsmg/kg/day
82TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals82FEEDREGFeeding RegimenAd Libitum
83TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals83TKDESCToxicokinetic DescriptionNON-TK
84TDM4TX3F1RHigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, Recovery animals84SPLANSUBPlanned Number of Subjects6
85TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals85ARMCDArm Code3
86TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals86SPGRPCDApplicant-Defined Group Code3
87TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals87GRPLBLGroup LabelGroup 3, 100 mg/kg/day
88TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals88TRTDOSDose Level100
89TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals89TRTDOSUDose Unitsmg/kg/day
90TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals90FEEDREGFeeding RegimenAd Libitum
91TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals91TKDESCToxicokinetic DescriptionTK
92TDM4TX3F1THigh-Dose Group, 100 mg/kg Compound A once daily, Fed Ad Libitum, TK animals92SPLANSUBPlanned Number of Subjects6
93TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet93ARMCDArm Code3
94TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet94SPGRPCDApplicant-Defined Group Code3
95TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet95GRPLBLGroup LabelGroup 3, 100 mg/kg/day
96TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet96TRTDOSDose Level100
97TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet97TRTDOSUDose Unitsmg/kg/day
98TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet98FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
99TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet99TKDESCToxicokinetic DescriptionNON-TK
100TDM4TX3F2High-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet100SPLANSUBPlanned Number of Subjects8
101TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals101ARMCDArm Code3
102TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals102SPGRPCDApplicant-Defined Group Code3
103TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals103GRPLBLGroup LabelGroup 3, 100 mg/kg/day
104TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals104TRTDOSDose Level100
105TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals105TRTDOSUDose Unitsmg/kg/day
106TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals106FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
107TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals107TKDESCToxicokinetic DescriptionTK
108TDM4TX3F2THigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK Nonrecovery animals108SPLANSUBPlanned Number of Subjects6
109TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals109ARMCDArm Code3R
110TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals110SPGRPCDApplicant-Defined Group Code3
111TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals111GRPLBLGroup LabelGroup 3, 100 mg/kg/day
112TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals112TRTDOSDose Level100
113TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals113TRTDOSUDose Unitsmg/kg/day
114TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals114FEEDREGFeeding RegimenRestricted Diet (50g/animal/day)
115TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals115TKDESCToxicokinetic DescriptionTK
116TDM4TX3F2TRHigh-Dose Group, 100 mg/kg Compound A once daily, Restricted Diet, TK w/Recovery animals116SPLANSUBPlanned Number of Subjects6
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