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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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| Dataset2 |
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| Row | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
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| 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 |
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There are 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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| Dataset2 |
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| Row | STUDYID | DOMAIN | ARMCD | ARM | TAETORD | ETCD | ELEMENT | TABRANCH | EPOCH |
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| 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 |
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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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