11 January 2012

In December 2011, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Combination Drug Toxicity Testing. This new section was added to the three existing topics finalised in June 2011 and the Q&A document was renamed R1.

The updated M3(R2) Q&A document is available for download from the M3 Section on the Multidisciplinary Guideline page.