Drug Development Assumptions Log
This is a practical guide to building a assumptions log for a drug development project — a register of the assumptions the plan depends on, to be validated, adapted to the realities of developing a pharmaceutical product through regulatory stages.
What a Assumptions Log is
A assumptions log is a register of the assumptions the plan depends on, to be validated. For the full concept and how it works in general, see Project Assumption. On a drug development project it plays the same role, tuned to this kind of work.
Why it matters for a Drug Development project
Drug Development projects live or die on developing a pharmaceutical product through regulatory stages. A well-built assumptions log gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how drug development projects drift into avoidable delay and cost.
What to include
- Assumption
- Impact if wrong
- Owner
- Validation status
Drug Development-specific considerations
Tailor the assumptions log to the risks that most often derail drug development projects:
- Regulatory approval delays
- Trial/validation failures
- Strict GxP compliance
Example
On a real drug development project, the assumptions log would be shaped by developing a pharmaceutical product through regulatory stages. In particular, it should explicitly account for the project’s biggest risks — regulatory approval delays, trial/validation failures, strict GxP compliance — rather than treating them as afterthoughts.