Clinical investigation of immunosuppressants for solid organ transplantation - Scientific guideline

This 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.

Keywords: Immunosuppressants, solid organ transplantation

Current effective version

Guideline on clinical investigation of immunosuppressants for solid organ transplantation

Adopted Reference Number: CHMP/EWP/263148/06 Legal effective date: 01/02/2009

Document history

Overview of comments received on draft guideline on clinical investigation of immunosupressants for solid organ transplantation

Reference Number: EMEA/377225/2008

Draft guideline on clinical investigation of immunosuppressants for solid organ transplantation

Draft: consultation closed Reference Number: CHMP/EWP/263148/06

Concept paper on the development of a CHMP guideline on clinical investigation of immunosuppressants for solid organ transplantation

Reference Number: CHMP/EWP/263148/2006