A review on the role of extrapolation as basis for paediatric marketing authorization applications of medicines in the EU
Charlotte W. M. Simons, Maaike van Dartel, Michiel van den Heuvel, Loes den Otter et autres
AIMS: For new medicines, drug companies obtain regulatory approval on the strategy to generate evidence in the paediatric population, which can be supported by extrapolation of evidence obtained in a reference population. This study investigated whether paediatric marketing authorization applications (PMAAs) supported …
nl (code pays fourni par la source)
3 citations
British Journal of Clinical Pharmacology