Clinical Drug-Drug Interaction (DDI) Studies
Characterize DDI Risk with Confidence. Before It Reaches the Clinic.
Quantitative LC-MS/MS assays aligned to EMA and FDA DDI guidance, supporting in vivo studies from single probe to complex multi-cohort designs.
Drug-drug interactions (DDI) pose a significant safety risk in the development of new medicines.
With an aging global population and a corresponding rise in polypharmacy, incidences of harmful and potentially fatal side effects of DDIs are expected to increase.
This means it’s important to assess the potential DDIs during drug development and ensuring they are sufficiently characterized prior to market approval of medicines.
Reach out to us directly to learn more about Resolian’s services relating to Clinical Drug-Drug Interaction Studies.
In Vivo DDI Study Experience
Resolian’s LC-Bioanalysis department has considerable experience supporting in vivo DDI studies performed during the clinical phase of drug development.
- Quantitation of investigational drug and single probe/inhibitor drug
- PK parameter analysis
- Partial validation to assess assay performance in presence of DDI probes/inhibitor drugs
- Larger, complex studies assessing investigational drugs and multiple DDI probes/inhibitors across multiple cohorts
Resolian offers you a portfolio of in-house quantitative LC-MS/MS assays, with an emphasis on the probe drugs and inducers/inhibitors recommended in guidance issued by the EMA and FDA.
Why Choose Resolian for DDI Bioanalysis?
Resolian’s LC-bioanalysis team brings more than validated methods to your DDI program. We bring a strategy.
Our in-house portfolio of quantitative LC-MS/MS assays covers the probe drugs, inducers, and inhibitors recommended in current EMA and FDA DDI guidance, giving you immediate access to tried-and-tested methods without the time and cost of development from scratch. For studies with novel investigational drugs, we conduct partial validation to confirm assay performance in the presence of your specific DDI probes or inhibitors, before a single clinical sample is analyzed.
We support the full range of DDI study designs: from straightforward single-probe quantitation to complex multi-cohort studies assessing multiple DDI probes and inhibitors simultaneously. Integrated PK parameter analysis and regulatory-ready reporting are included as standard.
Our portfolio of non-proprietary methods is available on request. Contact us to discuss your study design and we will confirm which validated assays are available for your program.
Ready to support your clinical DDI program?
Partner with an experienced LC-bioanalysis team that offers a portfolio of validated probe drug methods, partial validation expertise, and full regulatory alignment to keep your development program on track.
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