Development
Clinical Pharmacology & Therapeutics (2008); 83, 4, 622–626. doi:10.1038/sj.clpt.6100492
Assessing Abuse Liability During Drug Development: Changing Standards and Expectations
KA Schoedel1 and EM Sellers1,2,3,4
- 1Clinical Pharmacology Group, DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada
- 2Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada
- 3Department of Medicine, University of Toronto, Toronto, Ontario, Canada
- 4Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
Correspondence: KA Schoedel, (k.schoedel@dlcrc.com)
Received 2 November 2007; Accepted 28 November 2007; Published online 23 January 2008.
Abstract
As public health concerns have changed, regulatory expectations for assessing abuse liability of new central nervous system (CNS) drugs have increased. All CNS-active drugs with any properties indicating stimulant, depressant, hallucinogenic, or mood-elevating effects will require an evaluation of abuse liability. Abuse liability assessment involves the collection, analysis, and interpretation of data on chemistry and tampering, animal behavioral pharmacology, clinical trial adverse events (AEs), diversion and overdose, and potentially reinforcing (subjective) effects in recreational drug users.
