Drug-drug interactions (DDI) and food effects (FE) on bioavailability can have clinically significant consequences. As such, the FDA and other regulatory authorities require that sponsors evaluate the potential for DDI and assess the impact of food on the pharmacokinetics of most compounds. Sponsors can streamline the road to approval by leveraging the positions of regulatory authorities in determining when clinical studies will be required and if necessary, when those clinical studies could be combined (i.e. cocktail studies).
Medpace is uniquely positioned to support your DDI and FE studies. Our one-of-a-kind research campus in Cincinnati, OH provides a highly collaborative and efficient environment for executing these studies. Located on the campus:
- In-house scientific and regulatory experts who can assist with the Clinical Pharmacology strategy
- 60-bed Phase I unit with access to a robust database of healthy volunteers. Extensive prescreening is done to ensure the right participants are enrolled
- Bioanalytical Laboratory located next door to the Phase I Unit to expedite receipt and processing of PK samples
How we can help with DDI and FE studies:
- Leverage the latest FDA and EMA guidelines to determine if clinical studies are in fact necessary and, if so, when studies can be combined
- Determine best timing for performing studies to de-risk the development program
- Design studies
- Provide guidance for regulatory requirements by geography
- Develop PK blood sampling schedules that can adequately estimate a drug’s pharmacokinetic profile with precision
