Module232025

07/05/2025

Maturation of systems important for ADME such as the gastrointestinal, liver and renal systems can result in rapidly changing systemic exposures in humans and in animals, leading to potential age-related differences in efficacy and toxicity. In humans, these differences are usually most prominent in neonates and infants. In general, a JAS is not informative in predicting or recapitulating age-related differences in human ADME.

The Organisation for Professionals in Regulatory Affairs

17

Existing nonclinical data should be evaluated for findings that could indicate potential effects in organs undergoing development in paediatric subjects. Findings occurring in animals at similar exposures as those likely to be achieved in paediatric subjects are of increased concern, particularly if the findings occur in organs/tissues that undergo critical postnatal development at the intended paediatric age. Safety signals in adult animals in more than one species are of increased concern..

The Organisation for Professionals in Regulatory Affairs

18