Current Status of Juvenile Animal Studies and Future Issues

Abstract

Pediatric drug development has been an important part of the drug-development process. To support pediatric drug development, pharmaceutical companies will develop a strategy and assess the need to perform juvenile animal studies (JAS). JAS are conducted depending on known information such as clinical context, pharmacology, clinical/nonclinical data, etc., of developing pharmaceuticals on a case-by-case basis. When JAS are judged to be needed, an appropriate study should be designed to address possible safety concerns for the pediatric population. However, lack of harmonization among the regulatory regions on criteria used to determine the need of JAS, and on specific aspects of study design, complexifies the conducting of JAS. In this review, background and current status of JAS are outlined. Key points when judging the need for JAS and designing JAS are introduced based on the current discussion in ICH S11. In addition, current issues of JAS are also discussed.