Scientific Resources: Regulatory Guidance

AAPS-FDA Drug Transporters

The American Association of Pharmaceutical Scientists (AAPS) and U.S. Food and Drug Administration (FDA) co-sponsored the workshop “Drug Transporters in ADME:...

In Vitro DDI Regulatory Guidance Reference Poster

At the 2018 Marbach Castle Drug-Drug Interaction Workshop in Germany, Dr. Brian Ogilvie, Vice President of Scientific Consulting, presented a comparison...

Initial Impressions of New Draft FDA DDI Guidance Documents from XenoTech

Updated Nov. 6th, 2017 The FDA has released its long-awaited new draft guidance for industry on drug-drug interaction (DDI) studies....

Considerations In Response to Drug-Drug Interaction Guidances

Check out the recent IQ consortium publication: Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidances from...