Module232025

07/05/2025

The WoE approach should be applied to determine whether additional nonclinical investigations are warranted, with emphasis on the factors considered most important to inform the clinical risk assessment. When a study is deemed warranted, the specifics of the identified safety concerns should define the aim of the nonclinical investigation - this could be a JAS or another study ( e.g., in vitro or ex vivo investigations). For a JAS, the study objectives should be aligned with the WoE outcome and the intended paediatric use . This is essential to appropriately design and customise the JAS with regard to the treatment period and endpoints to be included.

The Organisation for Professionals in Regulatory Affairs

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The ICH S11 guideline devotes almost half of the text to the design of JAS, and includes advice on species, age of animals, duration of dosing, dose selection, core endpoints, other endpoints, growth, sexual development, clinical pathology, toxicokinetics, bone assessments, CNS assessments, pathology and histopathology , reproductive assessments and immunological assessments.

The Organisation for Professionals in Regulatory Affairs

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