First-in-Human Assessment v2
Integrate toxicology, HED/MRSD, fit-for-purpose MABEL, pharmacologically active dose, exposure margins and early-phase risk controls. The output is a starting-dose ceiling for multidisciplinary review—never authorization to dose humans.
1 · Programme context
The calculator does not create a clinical identity. When opened from Clinical Development OS, results can be saved to the same programme/candidate evidence ledger.
2 · Traceable toxicology anchor
NOAEL/HED/MRSD is only one anchor. Study identity and species relevance are mandatory for decision-qualified use.
3 · MABEL / model-informed anchor
Decision-grade QSP/PK-PD MABEL requires exact model identity, context of use, risk/impact assessment and evaluation. The simple receptor-occupancy equation is fenced as exploratory.
Exploratory receptor-occupancy inputs
4 · PAD / target-exposure anchor
Supportive model-derived evidence must be linked to a model version and measured source evidence. It never replaces toxicology.
5 · Integrated risk & early-phase controls
Risk controls are explicit. High/very-high uncertainty drives an internal sentinel/staggering gate; stopping rules and maximum exposure/dose criteria are always required for the software transition.
6 · Multidisciplinary review checklist
Checking these boxes records inputs to the assessment only. A separate explicit reviewer action is required to append REVIEWED evidence to the programme ledger.
Assessment output
The proposed ceiling is a conservative quantitative anchor for human review—not a prescription, protocol instruction or authorization.
No final starting dose is selected by this software.