Module232025

07/05/2025

As eloquently stated by Swiss developmental psychologist Jean Piaget in 2001, “Children are not miniature adults”. • Developmental Stages: Children are constantly growing and developing, undergoing physical, cognitive, and emotional changes at different rates and in ways that are not simply scaled-down versions of adult development. • Physiological Differences: Children have differences in organ systems, metabolic rates, and drug responses compared to adults. For example, their immune systems are still developing, and their blood-brain barriers are more permeable.

The Organisation for Professionals in Regulatory Affairs

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Paediatric patients who can receive pharmaceuticals during periods of rapid growth and/or postnatal development of several organ systems, therefore, represent a distinct population when compared to adults. Immaturity of organ systems and maturation of systems during drug treatment can affect drug pharmacokinetics (PK), pharmacodynamics (PD), and/or off-target effects of pharmaceuticals, potentially leading to differences in safety and/or efficacy profiles between paediatric populations (as described in ICH E11) and/or when compared to adults.

The Organisation for Professionals in Regulatory Affairs

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