Module232025

09/05/2025

Pediatric extrapolation

Multidisciplinary(! ) assessment of similarities between populations (adults, adolescents, children, neonates…), identify gaps and uncertainties • disease (or condition), • drug pharmacology, • response to treatment • Physiologic changes and organ maturation • differing rates between neonates, toddlers, young children Options for study designs, methods and analyses will depend on the gaps in knowledge and the level of uncertainty that needs to be resolved. • the pediatric extrapolation plan itself can be modified to reflect emerging scientific and clinical understanding

The Organisation for Professionals in Regulatory Affairs

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Pediatric extrapolation

Pediatric extrapolation plan should include: • objectives(s) • methodological approaches for the data that need to be generated to: • confirm assumptions • address uncertainties and gaps in knowledge • support benefit/risk assessment in the target population for the purpose of regulatory decision-making.

The Organisation for Professionals in Regulatory Affairs

16