Regulatory Documents

2017 FDA Guidance for Industry

Published:  25 October 2017

In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies - DRAFT GUIDANCE

2017 Japanese PMDA Guidance

Published:  04 September 2017

Pharmaceuticals and Medical Devices Agency of Japan (PMDA) Drug Interaction Guideline
for Drug Development and Labeling Recommendations (draft)

2012 EMA Guidance

Published:  03 October 2013

European Medicines Agency Guideline on the Investigation of Drug Interactions.
Revised June 2012

2012 FDA Guidance for Industry

Published:  14 May 2012

Drug Interaction Studies- Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations - DRAFT GUIDANCE

2010 Guideline on the Investigation of Drug Interactions - EMA

Published:  22 April 2010

The European Medicines Agency released their "Guideline to the Investigation of Drug Interactions" draft guidance on April 22, 2010.