Assessing abuse liability during drug development: changing standards and expectations.
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.
Schoedel
K A
KA
Clinical Pharmacology Group, DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada. k.schoedel@dlcrc.com
Sellers
E M
EM
D002170:Canada; D002492:Central Nervous System Depressants / Q000009:adverse effects; D000697:Central Nervous System Stimulants / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D011619:Psychotropic Drugs / Q000009:adverse effects*; D019966:Substance-Related Disorders / Q000209:etiology*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D002492:Central Nervous System Depressants; D000697:Central Nervous System Stimulants; D011619:Psychotropic Drugs