uid stringclasses 10
values | dataset_id stringclasses 1
value | year int64 2.02k 2.02k | therapeutic_area stringclasses 6
values | program stringclasses 10
values | starting_dose_justified stringclasses 2
values | exposure_projection_valid stringclasses 2
values | tox_margin_clear stringclasses 2
values | safety_monitoring_defined stringclasses 2
values | biomarker_plan_ready stringclasses 2
values | escalation_rules_clear stringclasses 2
values | package_alignment stringclasses 3
values | sponsor_summary stringclasses 10
values | question stringclasses 1
value | ground_truth_label stringclasses 2
values | ground_truth_rationale stringclasses 10
values | outcome_signal stringclasses 5
values | source_citation stringclasses 1
value |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FIH-TR-001 | pharma-first-in-human-readiness-coherence-v0.1 | 2,024 | Oncology | PROG_A | yes | yes | yes | yes | yes | yes | high | Starting dose from NOAEL with exposure model; monitoring and biomarkers defined. | Is FIH readiness coherent. Answer coherent or incoherent. | coherent | All entry elements aligned. | fih_ready | Synthetic |
FIH-TR-002 | pharma-first-in-human-readiness-coherence-v0.1 | 2,024 | Oncology | PROG_B | no | no | no | no | no | no | low | Dose chosen from competitor program; weak PK model; no biomarker plan. | Is FIH readiness coherent. Answer coherent or incoherent. | incoherent | Entry unsupported by tox and PK. | fih_delay_risk | Synthetic |
FIH-TR-003 | pharma-first-in-human-readiness-coherence-v0.1 | 2,023 | Cardiology | PROG_C | yes | yes | yes | yes | yes | yes | high | Clear margin and escalation rules; telemetry monitoring included. | Is FIH readiness coherent. Answer coherent or incoherent. | coherent | Strong alignment across package. | fih_ready | Synthetic |
FIH-TR-004 | pharma-first-in-human-readiness-coherence-v0.1 | 2,023 | Cardiology | PROG_D | yes | no | no | yes | no | no | medium | Tox margin narrow and exposure uncertain. | Is FIH readiness coherent. Answer coherent or incoherent. | incoherent | Margin and exposure conflict. | hold_risk | Synthetic |
FIH-TR-005 | pharma-first-in-human-readiness-coherence-v0.1 | 2,022 | Neurology | PROG_E | yes | yes | yes | yes | yes | yes | high | CNS exposure predicted; sentinel dosing planned. | Is FIH readiness coherent. Answer coherent or incoherent. | coherent | Appropriate safety structure. | fih_ready | Synthetic |
FIH-TR-006 | pharma-first-in-human-readiness-coherence-v0.1 | 2,022 | Neurology | PROG_F | no | no | no | no | no | no | low | Escalation plan unclear and no biomarker readout. | Is FIH readiness coherent. Answer coherent or incoherent. | incoherent | Missing core readiness elements. | delay_likely | Synthetic |
FIH-TR-007 | pharma-first-in-human-readiness-coherence-v0.1 | 2,021 | Rheumatology | PROG_G | yes | yes | yes | yes | yes | yes | high | Exposure-response model supports starting dose. | Is FIH readiness coherent. Answer coherent or incoherent. | coherent | Aligned PK tox and monitoring. | fih_ready | Synthetic |
FIH-TR-008 | pharma-first-in-human-readiness-coherence-v0.1 | 2,021 | Rheumatology | PROG_H | yes | no | no | yes | no | no | medium | Dose justified but exposure uncertain and biomarkers missing. | Is FIH readiness coherent. Answer coherent or incoherent. | incoherent | Incomplete readiness. | hold_risk | Synthetic |
FIH-TR-009 | pharma-first-in-human-readiness-coherence-v0.1 | 2,020 | Infectious Disease | PROG_I | yes | yes | yes | yes | yes | yes | high | Pathogen load biomarker supports early readouts. | Is FIH readiness coherent. Answer coherent or incoherent. | coherent | Full readiness alignment. | fih_ready | Synthetic |
FIH-TR-010 | pharma-first-in-human-readiness-coherence-v0.1 | 2,020 | Metabolic | PROG_J | no | no | no | no | no | no | low | Starting dose chosen for speed rather than data. | Is FIH readiness coherent. Answer coherent or incoherent. | incoherent | Unsafe and unjustified entry. | program_risk | Synthetic |
What this repo is for
decide if a program is ready for first human dosing
stop unsafe or premature entry
support internal governance boards
support regulatory prep
guide escalation planning
You now have the full biology stack from target → preclinical → biomarker → FIH.
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