Module232025

12/05/2025

Formulation

•Is there a need for a paediatric one? •Is the adult one adaptable?

• Components

• Expected volumes • Expected strenght

What is the formulation proposed?

•How do we know?

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Non-clinical development - safety and proof of concept

•Is there a need for a paediatric one? •Is the adult ne adaptable? Signals from existing data?

What is the formulation proposed? What types of studies have been performed? Need of additional non clinical proof of concept data? Do animal models exist?

• Components Are studies in juvenile • Expected volumes • Expected strenght animals needed?

•How do we know?

16

Frontiers | From guideline to practice: three years of ICH S11 insights and recommendations

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