Drug-Drug Interaction (DDI) Studies in Clinical Pharmacology

In Vivo 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 highlights the importance of assessing potential DDIs during drug development and ensuring they are sufficiently characterised prior to market approval of medicines.

Supporting your clinical DDI study areas

At our Cambridge (Fordham) facility our LC-MS 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.