Drug-drug Interaction (DDI) Studies
Drug-drug Interaction (DDI) Studies Services
Pharmacokinetic-based drug-drug interactions (DDIs) can be a major issue during drug development. As populations expand and life expectancy increases, the extent and frequency of patients being prescribed multiple concomitant medications is growing. Consequently, the potential risks for adverse drug interactions due to DDIs occurring is also increasing. To help our partners minimize these risks in new drugs, Pharmaron offers an expansive portfolio of drug-drug interaction services.
Pharmaron offers a comprehensive range of in vitro assays designed to meet the requirements of the latest regulatory DDI guidance published by the FDA (2020) and JMHLW (2018). GLP studies can be conducted for regulatory submission.
Capabilities
Assays
- CYP Inhibition
- CYP Induction
- CYP Reaction Phenotyping
- UGT Inhibition
- UGT Reaction Phenotyping
- Other Enzyme Reaction Phenotyping
- ABC Transporter Phenotyping
- ABC Transporter Inhibition
- SLC Transporter Phenotyping
- SLC Transporter Inhibition
DDI Expertise
- Enzyme-mediated DDI assays (CYP, UGT and other enzymes)
- Drug transporter-mediated DDI assays (ABC and SLC transporters)
- in vitro assays with both radiolabelled and/or non-labelled test compounds
- QA’d or non-QA’d regulatory compliant studies
- Expert data review and interpretation by senior in vitro scientists
- Customized in vitro programs to meet client-specific needs
Integrated Services
- Metabolite profiling and identification
- Radiosynthesis
- in vivo ADME/DMPK
- Regulatory bioanalysis
- Clinical metabolism
- Clinical DDI studies
0
