Clinical investigation of immunosuppressants for solid organ transplantation

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Current effective version

Adopted guideline

Reference numberCHMP/EWP/263148/06
Effective from01/02/2009
KeywordsImmunosuppressants, solid organ transplantation
DescriptionThis document provides guidance on the conduct of clinical studies for solid organ transplantation. It definines treatment goals, study designs, outcome measures and data analysis for new immunosuppressive products developed to prevent and treat solid organ allograft rejection.

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/11/2010–present

Published: 16/07/2008

Published: 19/07/2007

Published: 24/01/2007

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