BioPharma Services Inc. offers comprehensive services for the conduct of Human Abuse Liability Studies.

A sponsor must submit in the NDA an assessment of studies and other information related to the potential abuse of a drug and include a proposal for scheduling, if the drug affects the central nervous system (CNS), is chemically or pharmacologically similar to other drugs with known abuse potential, or produces psychoactive effects such as sedation, euphoria, and mood changes (21 CFR 314.50(d)(5)(vii)).1

When developing opioid drug products with potentially abuse-deterrent properties, data from the following three categories of studies should be included in the submission:

  1. Laboratory-based in vitro manipulation and extraction studies3pic2
  2. Pharmacokinetic studies
  3. Clinical abuse potential studies

Sponsors are expected to consider both the mechanisms by which abusers can be expected to attempt to deliberately overcome the abuse-deterrent properties of the product as well as the ways that patients may alter the formulation (unintentionally or intentionally) that change the rate or amount of drug released (e.g., dose dumping may occur when taking the product with alcohol or when the product is cut, chewed, or crushed).2

BioPharma Services, in collaboration with software vendors and other partners, utilizes a proprietary electronic software for collection of pharmacodynamics scales required for human abuse liability studies. This system includes Visual Analog Scales derived from Addiction Research Center Inventory questionnaire as well as Cognitive Assessment module. The advantages of computerized assessments are a touch-screen tablet format for ease-of-use by study subjects and clinical staff, collection of accurate automated outcome measures, and provision of electronic datasets, all captured within a 21 CFR Part 11 compliant system.

Human Abuse Liability – The BioPharma Advantage

FDA Guidance 2010: Assessment of Abuse Potential of Drugs
FDA Guidance 2013 : Abuse-Deterrent Opioids — Evaluation and Labeling