Juvenile animal studies in the development of pediatric medicines: experience from European medicines and pediatric investigation plans.

INTRODUCTION

The need for early consideration of pediatric investigation plans (PIP) to support an indication in pediatric population has led to an increased focus on the relevance of nonclinical studies in juvenile animals (JAS). The usefulness of JAS is not yet established and a criterion for request is still a learning process.

OBJECTIVE

This article compares data from JAS in all medicines approved by European centralized procedure before Pediatric Regulation (1995-2005) and data from JAS in the nonclinical information on all approved PIP (2007-2009).

RESULTS

Of the 226 substances licensed by centralized procedure in 10 years, 31.9% were considered for children and 31 JAS were described in 9.7%. Since 2007, of the 205 PIP decisions, 50 PIP (24.3%) have 87 JAS planned or requested. The mean number of JAS in each medicine or PIP, increased from 1.4 to 1.7 between the two periods and the juvenile rat remained as the prevalent species.

CONCLUSIONS

Results demonstrate that JAS planned/performed in EU environment has significantly increased.