Drug abuse and potential drug abuse are critical issues for today’s pharmaceutical industry and the health of patients. Understanding the latest FDA regulatory requirements, different study types, relevant timelines and logistics can be challenging. Conducted at a critical stage of drug development, the assessment for drug abuse potential is complex and must be acceptable to regulators.
If a drug or its major metabolite penetrates the brain, then an abuse potential assessment is required, regardless of the therapeutic indication.
Developing a strategy around relevant timelines
The doses for drug abuse testing are selected based on the exposure/plasma levels produced in humans by the highest therapeutic dose. Therefore, drug abuse studies are not recommended until the human therapeutic dose range has been determined; however, your testing strategy should begin much earlier.
An experienced consultant will provide an overall evaluation of abuse liability, taking into consideration nonclinical and clinical data generated throughout development to support your regulatory filing. In addition to helping develop your testing strategy, we will support your regulatory agency meetings and interactions with regulators.
Topics in our series on assessing a drug’s potential for abuse
FDA, EMA and ICH M3 (R2) guidance require GLP self-administration, drug discrimination and physical dependency studies be conducted if a drug or its major metabolite penetrates the brain. Over the next few months, we’ll delve deeper into these in vivo testing requirements, and along the way share with you some of our in-house data.
We will link each of the articles in the series here as they’re posted: