Clinilabs, the US-based contract research organisation (CRO) focused on early-phase and speciality drug-development services, has started offering comprehensive human abuse-liability (HAL) testing at its Phase 1 units in New York City and New Jersey.
The Food and Drug Administration (FDA) estimates that nearly 12% of the US population uses prescription drugs for non-medical purposes, Clinilabs noted.
In an effort to manage this problem, the FDA and the US Drug Enforcement Administration have issued strict guidelines for drug manufacturers developing products with high potential for abuse.
These include HAL assessments on recreational drug users for all medicines affecting the central nervous system that are chemically or pharmacologically similar to other drugs with known abuse potential, or that produce psychoactive effects such as sedation, euphoria or mood changes.
Despite these requirements and a growing demand for associated data, only a small number of organisations currently offer HAL testing, and only one of these is located in a major metropolitan area of the US, Clinilabs pointed out.
Expert team
The company is offering access to a team of “world-renowned leaders” in abuse liability, as well as experts in clinical drug development with “a deep understanding of current regulatory guidance, study methodology, clinical care, biostatistics, and medical writing for the assessment of abuse liability”.
Clinilabs has integrated the HAL study team into its organisation and placed them in “the metropolitan area with the largest diverse population in the world in order to deliver exceptional value to our clients”, it said.
The new service will feature at the ASCPT (American Society for Clinical Pharmacology and Therapeutics) conference in Atlanta, Georgia, which runs from 18-22 March 2014.
