Bioequivalence and Bioavailability Forum

Dear all,
I need to perform in adults a bioequivalence study for a pediatric formulation.
It is known that the time to reach peak plasma levels in children is delayed with almost one hour compared to the adult population.
In the CHMP "Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population" is specified that "If there are reasons to believe that the absorption from a formulation may be significantly different in certain paediatric age-groups, supportive data in the paediatric population may be needed".

This difference in Tmax between children and adults may be a reason to change the population included in the study and to not conduct the study in healthy adults?

Best regards, Ioanam

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Edit: Category changed. [Helmut]