Juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in children

Current effective version

PDF iconProject report

Reference numberEMA/629174/2017
Published30/11/2017
Effective from24/02/2017
Keywordspaediatric, juvenile animal study, JAS, oncology
Description

Special scientific considerations apply to developing medicinal products for children because of their heterogeneity and potential for differences compared to adults. Several non-clinical and clinical EMA and ICH scientific guidelines address evaluating medicines in the paediatric population, including studies in juvenile animals (JAS), studies in specific populations such as neonates, and paediatric therapeutic areas such as for anti-cancer medicines.

This project, conducted by EMA and members of the Non-clinical Working Group of the PDCO, was aimed to assess the impact and the utility of JAS on paediatric medicinal product development, and the example of anti-cancer medicines was chosen as they are expected to show toxicity that most likely affects developing tissues and organs, in both humans and animals. The results of this project can help to build up experience on the utility of the juvenile studies and contribute to shape the future requirements from PDCO, assessments as well as to review how juvenile animal studies inform how to better evaluate anticancer medicines, protect and treat young children with cancer.

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