Define differentiation before dosing
Write the exposure, pharmacodynamic or tolerability threshold that would make the program meaningfully different.
Choose measurements that affect the next decision
Do not collect biomarker or exploratory data simply because they are available. Ask which results change dose, indication, capital or partnering decisions.
Predefine stop/modify rules
The management decision should be written before ambiguous results arrive.
Questions people actually ask
FAQ
Is Phase 1 only about safety?
Safety is central, but many Phase 1 programs also seek PK, PD, dose, tolerability and early biologic information.
Why predefine a decision gate?
Because it reduces the temptation to reinterpret ambiguous data after the fact.
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