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W 23: Use of Juvenile Animal Studies to Support Oncology Medicine Development in Children
Scientific Evaluation Unit, Directorate of Medicinal Products
Juvenile animal studies (JAS) can contribute significantly to risk assessment and safety in paediatric clinical trials and for drug product labelling, and their usefulness will be examined in oncology medicines, primarily from a regulatory standpoint.
Critical analysis of nonclinical information on all approved European Public Assessment Reports concerning existence of JAS, species and data from JAS in the nonclinical information on all approved paediatric investigation plans to support an oncology indication in paediatric population.
The prediction of non-clinical models is rather limited and extrapolation of animal results to the human situation in oncology medicines should be performed with caution. The needs for early consideration of paediatric population (PP) have led to an increased focus on the relevance of nonclinical studies in juvenile animals.
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 juvenile toxicity studies in advanced cancer patients is of importance. Discuss the importance and value of nonclinical juvenile animal studies for oncology medicines. Share real world experience from available historical data on juvenile animal studies towards paediatric use and build up the experience on utility of juvenile studies in therapeutic area of oncology.