Monday, December 6, 2010

E2F: Development Safety Update Report

Development Safety Update Report


The tripartite harmonised ICH guideline was finalised (Step 4) in August 2010.
The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.

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