Labcorp, Charles River Laboratories and the FDA have formed a research collaboration to improve preclinical methods for assessing whether new medicines could be abused.
The partners will use harmonized behavioral economics methods to quantify and rank abuse potential. Their goal is to strengthen the evidence used during drug development and regulatory review and improve predictions of how medicines and emerging substances may be used outside controlled settings.
Labcorp will contribute experience conducting regulatory abuse potential studies. FDA scientists will analyze data and provide regulatory science expertise.
The research focuses on methods for evaluating abuse-related risks, rather than testing a particular medicine identified in the announcement.
Assessments of abuse potential can inform decisions about controlled-substance scheduling, product labeling and other regulatory requirements. Labcorp has conducted studies supporting these evaluations since 2009.
Brian Caveney, Labcorp’s president of biopharma laboratory services and chief medical and scientific officer, said the work could improve risk evaluation throughout development and regulatory review.
The collaboration also reflects efforts to understand changing patterns of drug use and the risks posed by emerging substances.
Labcorp’s toxicology capabilities include identifying and monitoring illicit substances and emerging synthetic drugs. That work provides information on drug-use trends and potential public health threats.
The partners aim to generate evidence that helps researchers connect preclinical assessments with potential real-world use patterns. Improved methods could support regulatory decisions intended to protect patients and communities.
The collaboration brings industry study experience together with government data analysis and regulatory science to examine how abuse potential is measured before medicines reach clinical use.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!