Stage 2 · Toolkit 2.12
First-in-Human Risk Assessment & Starting Dose
Justify starting dose, escalation, stopping rules, sentinel dosing, and safety review governance.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for First-in-Human Risk Assessment & Starting Dose.
How it helps your team
Surface evidence gaps and dependencies before they delay IND, CTA, or first-in-human decisions.
Designed for
Nonclinical development, toxicology, safety pharmacology, bioanalysis, Regulatory Affairs, and Quality teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- FIH Risk Assessment SOP
- Starting Dose Justification Template
- Dose Escalation Plan Template
- Sentinel Dosing Plan Template
- Stopping Rules Template
- Safety Review Committee Charter
- Dose Escalation Decision Memo
Excel workbooks
- Dose Escalation Tracker
- Safety Review Decision Log
- Emerging Safety Data Tracker
- Stopping Rule Trigger Tracker
- Cohort Decision Tracker
Related toolkits
Continue within stage 2
Nonclinical Development Plan & IND/CTA-Enabling Strategy
Define the nonclinical package needed to support IND, CTA, first-in-human, and clinical development.
2.2GLP Compliance & Sponsor Oversight
Ensure GLP studies are appropriately planned, overseen, monitored, documented, reported, and archived.
2.3Toxicology Study Planning & Management
Manage toxicology studies and interpret key findings for regulatory and FIH readiness.