Module232025

12/05/2025

Paediatric Development

Clinical Trials

Bridging studies

Non Clinical

The Organisation for Professionals in Regulatory Affairs

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Bridging studies

“when a medicinal product is to be used in the paediatric population for the same indication(s) as those studied and approved in adults, the disease process is similar in adults and paediatric patients, and the outcome of therapy is likely to be comparable, extrapolation from adult efficacy data may be appropriate. In such cases, pharmacokinetic studies in all the age ranges of pediatric patients likely to receive the medicinal product, together with safety studies, may provide adequate information for use by allowing selection of pediatric doses that will produce blood levels similar to those observed in adult”

Paediatric study decision tree (adapted from FDA’s Guidance to industry: exposure-response relationships - study design, data analysis, and regulatory applications 1993)

The Organisation for Professionals in Regulatory Affairs

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