Module232025

5/7/2025

Is there sufficient basis to proceed with paediatric trials?

Has a paediatric formulation been developed that is safe (e.g. acceptable excipients), permits accurate dosing, is palatable and supports compliance?

Data from in vitro / animal models relevant to paediatric age groups (juvenile animals) MOD + safety

Is the paediatricCT design appropriate for demonstration of

Think of dose selection , modeling

and simulation, population PK, biomarkers , extrapolation

benefit:risk and is it children friendly ?

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What are the desirable characteristic of an ‘age-appropriate’ dosage form ?

Paediatric formulations

• Delivers accurate and variable doses (age/weight/surface area). • Safe (excipients) • Acceptable to the child (Taste, appearance and texture). • Matched to child development and ability to take it (tablet size, volume of liquid, patient empowerment). • Prevents medication error.

Bioequivalence of adult and paediatric formulations can be studied in adults but :  food effects are more critical for paediatric administration

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