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Regulatory Documents

2020 FDA Draft Guidance, “Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry”

In August 2020, the FDA released the draft guidance for industry to evaluate therapeutic proteins for drug-drug interaction (DDI) potential using a risk-based approach.  ...

2020 FDA Final Guidance, “In Vitro Drug Interaction Studies– Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions”

We are proud to have been cited in this final guidance for industry document, which was released by the FDA in January 2020. Access full...

2019 PMDA Guideline (English Translation), “Guideline on drug interaction for drug development and appropriate provision of information”

In 2019, the Phamraceuticals and Medical Devices Agency (PMDA) in Japan released the official English translation of their guidance for industry. Drug developers may also...

2017 FDA Draft Guidance, “”In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies”

Published by the FDA in 2017, this is the Draft guidance for industry, “In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies” You might also...

2012 EMA Final Agency Guideline, “Guideline on the Investigation of Drug Interactions”

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...

2012 FDA Draft Guidance, “Drug Interaction Studies — Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations”

FDA 2012, Drug Interaction Studies- Study Design, Data Analysis, Implications for Dosing and Labeling Recommendations – DRAFT GUIDANCE Download Publication

2010 EMA Draft Guideline, “Guideline on the Investigation of Drug Interactions”

The European Medicines Agency released their “Guideline to the Investigation of Drug Interactions” draft guidance on April 22, 2010.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