Pediatrics & Therapeutics
Open Access
ISSN: 2161-0665
ISSN: 2161-0665
Dinah Duarte
INFARMED-Autoridade Nacional do Medicamento e Produtos de Saude, Portugal
Lusofona University, Portugal
Posters & Accepted Abstracts: Pediat Therapeut
When planning the pediatric development of any pharmaceutical, aspects that need to be taken into consideration include the understanding of potential for modified sensitivity vs. adults, unique toxicities or potential for effects on organ development. The need for early consideration of children has led to an increased focus on the relevance of nonclinical studies in juvenile animals (JAS). The immaturity of the developing organ may increase the potential for new target organs, modified activity or greater toxicity than has previously been seen in adults. While needing to screen for potential safety concerns associated to medicines use in children, avoiding useless studies and animal protection principles are strongly taken into consideration also. The need for animal studies for oncology drugs is in general a matter of controversy in particular for the most severe forms and the experience for JAS in advanced cancer patients is of importance. We intend to present a revision of results collected during the development of oncology pediatric medicines, towards pediatric use and build up the experience on utility of JAS. Also, a critical analysis of nonclinical information on all approved European Public Assessment Reports (EPARs: 1995��? 2014) concerning existence of JAS, pediatric therapeutic indication, and species and data from JAS in the nonclinical information on all approved pediatric investigation plans (PIPs) to support an indication in pediatric population (2007-2014). Further emphasis is placed on nonclinical support where PIPs refers to neonates and infants and the usefulness of such studies especially for tumors leading to short life expectancy.
Email: dinah.duarte@infarmed.pt