Module232025

07/05/2025

The nonclinical development plan for a paediatric pharmaceutical depends on an integrated assessment based on the totality of the evidence, including the clinical context together with the pharmacology, pharmacokinetic (ADME), and nonclinical in vitro and in vivo animal, and clinical safety data (adult and/or paediatric), i.e. , a WoE approach. A WoE approach considers multiple factors evaluated together and, therefore, a single factor should not be considered in isolation.

The Organisation for Professionals in Regulatory Affairs

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The importance of each factor should be considered such that the final decision concludes whether available data adequately address safety concerns in the proposed paediatric population or whether additional nonclinical studies would address those concerns. In addition, the translatability and biological relevance of the JAS data to humans should be considered.

The Organisation for Professionals in Regulatory Affairs

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