Module232025

12/05/2025

Considerations for a good PIP submission

Developmental differences: dose selection is a key process

Age-appropriate formulation(s): think about it early in drug dev process

Juvenile animal study: may add value regarding developmental tox

Ethical issues: protection from harm & information on medicineuse

Dose selection: consider & integrate all available information, M&S tools

Avoid unnecessary trials: is extrapolation possible?

Study feasibility: B/R, experienced centres, networks, approp. protocols,

consider optimizing adult study in view of paed dev

Long-term safety: long term safety FU, relevant developmental endpoints

Endpoints in context of study objective: clinically relevant, validated

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Stepwise PIP experience Life cycle management of a PIP

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