Overview of DDI Studies
Drug-Drug interactions (i.e., interactions between an investigational drug and other drugs administered to subjects/patients) must be evaluated during drug development for small molecules and biologics. Pharmacokinetic evaluation of drug-drug interactions via nonclinical and clinical studies can help determine if interactions between concomitantly administered drugs exist and if such interactions require a dosage adjustment or other measures to reduce risk to the target patient population. Drug-Drug interaction studies may evaluate the enzymes (CYP P450) and transporters involved in the drug’s metabolism and elimination or may investigate a potential interaction with other common concomitant medications administered in the target patient population.
Nuventra Services Provided for these Types of Studies
- Strategic planning for…
- the proper selection of an interacting drug (substrate, inhibitor, or inducer) for DDI studies
- Full clinical protocol development from clinical pharmacology experts
- Drug-Drug interaction clinical study design (DDI design)
- PK sampling schedule evaluation
- Topline assessment of food effect within 24 hours
- Full PK analysis (PK parameters) conducted in WinNonlin
- Full or abbreviated PK report
- Clinical study reports (CSRs) – with integrated PK data
- Investigator Brochure (IB) updates to clinical pharmacology and PK data
- FDA meetings or EMA meetings: Expert clinical pharmacology representation at regulatory meetings (including Briefing packet preparation)
- Interpretation of PK data to enable next steps in the development program
- Incorporation of data into model based drug development to allow for better decision making.
- Impact of study results on other planned clinical studies
- Although Nuventra does not enroll or dose subjects in clinical trials, our high level of experience with designing, executing and analyzing data from clinical pharmacology & PK/PD studies makes us the best option for clients needing advice in this area of drug development.
Example Drug-Drug interaction Clinical Study Design
An example of CYP inhibition one sequence crossover study is provided below. There are many DDI study designs to consider when planning your drug interaction study.
See our drug interaction reference page for more info on DDI studies
For more information or assistance please Contact us or request a quote.
When to Execute DDI Studies in Development Programs
Executing drug-drug interaction studies can be done throughout all phases of drug development and there are many considerations that go into when and how to conduct nonclinical and clinical drug interaction studies.
Let Nuventra’s clinical pharmacology consultants, pharmacokineticists, and drug development experts help intelligently integrate this study into your overall development efforts. Click here for a Clinical Pharmacology Plan.
Contact us or request a quote to help interpret the guidance to industry and with your drug development needs for this type of clinical pharmacology investigation.