ICH M12 Drug Interaction Studies Guidelines

M12 Drug Interaction Studies

M12 EWG Drug Interaction Studies

This topic was endorsed by the ICH Assembly in June 2018.

The M12 EWG is working on the development of a new M12 Guideline on “Drug Interaction Studies” with a view to providing a consistent approach in designing, conducting, and interpreting Drug-drug interactions studies during the development of a therapeutic product.

Guidelines (Click the links below for complete guidelines)

M12 Draft Guidelines

Endorsed Documents (Click the links below for complete guidelines)

M12 Concept Paper

M12 Business Plan

M12 Work Plan

*These Guidelines Belongs to ICH website.