Monoclonal Antibodies and Juvenile Animal Studies as a Model for Testing Toxicity in Children

Time

Wed, Jun 17 9:00AM
W 05

Title

Monoclonal Antibodies and Juvenile Animal Studies as a Model for Testing Toxicity in Children

Abstract Summary

Critical and retrospective analysis of European Medicines Agency (EMA) data – existence, number and design of JAS, paediatric indication and species - in approved mABs in the nonclinical information on all approved European Public Assessment Reports (1995 – 2014) and all PIPs (2007-2014).

Poster Presenter

Dinah Duarte
PharmD, MSc,
Head, Scientific Evaluation Unit, Directorate of Medicinal Products,
INFARMED
Portugal