Extrapolation of efficacy and safety in medicine development - Scientific guideline

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This 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.

Keywords: Extrapolation, medicine development, biostatistics, modelling, simulation

Current effective version

Concept paper on extrapolation of efficacy and safety in medicine development

Adopted Reference Number: EMA/129698/2012 Summary:

The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.

English (EN) (103.57 KB - PDF)

Pirmą kartą paskelbta: Paskutinį kartą atnaujinta:
Rodyti

Document history

Overview of comments received on 'Concept paper on extrapolation of efficacy and safety in medicine development'

Adopted Reference Number: EMA/184035/2013

English (EN) (489.57 KB - PDF)

Pirmą kartą paskelbta: Paskutinį kartą atnaujinta:
Rodyti

Concept paper on extrapolation of efficacy and safety in medicine development

Adopted Reference Number: EMA/129698/2012 Summary:

The concept paper is intended to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation.

English (EN) (103.57 KB - PDF)

Pirmą kartą paskelbta: Paskutinį kartą atnaujinta:
Rodyti

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