Clinical Drug-Drug Interaction (DDI) Studies
Supporting your clinical DDI Studies
Drug-drug interactions (DDI) pose a significant safety risk in the development of new medicines.
With an increasingly aging global population and a corresponding increase 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 characterised prior to market approval of medicines.
What is DDI (Drug-Drug Interaction (DDI) Studies)?
Drug-drug interactions (DDI) may occur when a patient is taking multiple medications simultaneously for one or more conditions.
In Vivo DDI Study Experience
Our 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
We have built 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.
| Enzyme | Analyte | Category |
| CYP1A2 | Tizanidine Enoxacin Fluvoxamine |
Probe drug Strong inhibitor Strong inhibitor |
| CYP2B6 | Efavirenz Ticlopidine |
Probe drug Strong inhibitor |
| CYP2C19 | Omeprazole Omeprazole Fluvoxamine |
Probe drug Moderate inhibitor Strong inhibitor |
| CYP2C8 | Repaglinide* Gemfibrozil |
Probe drug Strong inhibitor |
| CYP2C9 | Tolbutamide S-warfarin Fluconazole |
Probe drug Probe drug Moderate inhibitor |
| CYP2D6 | Desipramine* Paroxetine |
Probe drug Strong inhibitor |
| CYP3A | Midazolam* Itraconazole* Ritonavir |
Probe drug Strong inhibitor Strong inhibitor |
| CYP1A2, CYP2B6, CYP2C19, CYP2C8, CYP2C9, CYP2D6, CYP3A | Rifampicin | Strong/moderate inducer |
*Major active metabolites included
We also have 20+ additional methods in place for concomitant medications and transporter probes.
Contact us for the full list of non-proprietary methods.
