Concomitant medication use is widespread and presents a risk for patients in clinical trials and real world treatment settings. The risk is greater for older adults and patients with chronic conditions.
While automated warning systems act as a safeguard for patients prescribed licensed medications, protections against drug-drug interactions (DDIs) for clinical trials involving investigational medicinal products are often incomplete or inconsistent, leaving patients vulnerable to harmful adverse events.
The latest innovation built on Certara’s Drug Interaction Database (DIDB®) platform is the most complete, interactive list of drug interaction characteristics available today, with up to 5-6X the number of compounds and characteristics compared to publicly-available resources like the FDA and ICH. The Concomitant Meds Navigator is an essential, evidence-based tool for pharmaceutical sponsors and clinical researchers to greatly improve DDI management during clinical trials, particularly in early development when accurate instructions are challenging to obtain. By quickly identifying concomitant medications that are contraindicated, require dose adjustments, or need monitoring during the trial, the Navigator minimizes the risk of pharmacokinetic drug interactions and enables the safe and effective evaluation of investigational products.
In this webinar, you’ll get a better understanding of how to:
- Search a comprehensive list of drug characteristics including substrates, inhibitors and inducers for enzymes and transporters, anchored to marker studies, to assess potential DDI risk and inform clinical drug development strategies
- Improve drug labeling and provide greater clinical context with specific examples of concomitant medications related to your target patient population
- Interpret the deeper insight and nuance behind each classification by analyzing contextual information such as changes in exposure, supporting DDI and pharmacogenetic data, and pharmacokinetics detail