Development of medicinal products for the treatment of alcohol dependence - Scientific guideline

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This document provides guidance on the definition of treatment goals, study design, outcome measures, and data analysis for new medicinal products that will be developed to treat alcohol dependence.

Keywords: Alcohol dependence

Current effective version

Guideline on the development of medicinal products for the treatment of alcohol dependence

Adopted Reference Number: EMA/CHMP/EWP/20097/2008 Legal effective date:

English (EN) (219.67 KB - PDF)

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Document history

Guideline on the development of medicinal products for the treatment of alcohol dependence

Adopted Reference Number: EMA/CHMP/EWP/20097/2008 Legal effective date:

English (EN) (219.67 KB - PDF)

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Overview of comments received on the draft guideline on the development of medicinal products for the treatment of alcohol dependence (CHMP/EWP/20097/08)

Reference Number: EMA/626274/2009

English (EN) (352.52 KB - PDF)

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Draft guideline on the development of medicinal products for the treatment of alcohol dependence

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/20097/2008

English (EN) (172.46 KB - PDF)

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