Evaluation of anticancer medicinal products - addendum on paediatric oncology - Scientific guideline

This document is an addendum to the guideline on evaluation of anticancer medicinal products. 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

Current effective version

Note for guidance on evaluation of anticancer medicinal products on man: Addendum on paediatric oncology

Adopted Reference Number: EMEA/CPMP/EWP/569/02 Legal effective date: 01/01/2004