24 March 2014

In March 2014, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Concentration-Response RelationshipsCombination Products, Large Targeted Proteins and Monoclonal Antibodies and Special Cases. This new Q&As were added to the existing topics finalised by the E14 IWG in 2012 and the Q&A document was renamed R2.

The updated E14 Q&A document is available for download from the E14 Section on the Efficacy Guideline page.