Regulatory Documents

2017 FDA Guidance for Industry

Published:  25 October 2017

In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies - DRAFT GUIDANCE. You might also be interested in our webinar "Essential Considerations on the New FDA In Vitro DDI Guidance (the What, the Why, and the Wow)."

2017 Japanese PMDA Guideline-English Translation

Published:  15 September 2017

Approved registrants for our webinar comparing the new US FDA, European EMA and Japan PMDA in vitro DDI guidance documents will also receive access to our unofficial English translation of the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) Drug Interaction Guideline for Drug Development and Labeling Recommendations (draft) and related poster.

2017 Japanese PMDA Guideline

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. You might also be interested in our 2018 poster comparing current regulatory in vitro DDI guidance documents.

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Drug Interaction Studies- Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations - DRAFT GUIDANCE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The European Medicines Agency released their "Guideline to the Investigation of Drug Interactions" draft guidance on April 22, 2010.