Extrapolation of efficacy and safety in medicine development

  • Email
  • Help
Current effective version

Concept paper

Reference numberEMA/129698/2012
KeywordsExtrapolation, medicine development, biostatistics, modelling, simulation
DescriptionThis document aims to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.

Document history

First version

Current version

Concept paper

Overview of commnets

Draft concept paper

Published: 23/04/2013

Published: 23/04/2013

Published: 29/06/2012

Related content

How helpful is this page?

Average rating:

 Based on 31 ratings

Add your rating:

See all ratings
7 ratings
6 ratings
6 ratings
6 ratings
6 ratings

Tell us more