The situation
A paediatric plan is required, but recruiting children is slow, costly and ethically constrained.
What we do
- Judge how far disease, exposure and response extrapolate
- Scale PK to age and size, allowing for maturation
- Simulate doses per age band against the adult target
What you get
- An extrapolation rationale, uncertainty stated
- Doses by age band, with the simulations behind them
- A study design sized to the remaining question
Regulatory basis
ICH E11A sets out how far paediatric extrapolation can go and what must still be collected. E11(R1) asks that the approach be raised with regulators early.