Evaluation of anticancer medicinal products in man - addendum on paediatric oncology - Scientific guideline
Table of contents
This document is an addendum to the guideline on evaluation of anticancer medicinal products in man. It aims to complement the current guideline with specific regulatory requirements related to paediatric oncology. It provides more specific information on the design and conduct of phase I trials in paediatric patients.
Keywords: Childhood cancer, childhood malignancy, predictive model systems, xenograft models