International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Route Pré -Bois 20, P.O Box 1894, 1215 Geneva, Switzerland Telephone: +41 (22) 710 74 80- admin@ich.org, http://www.ich.org M12 Expert Working Group ICH M12 Guideline: DRUG INTERACTION STUDIES Questions and Answers M12 Q&As Adopted on 21 May 202 4