PMID- 18212799
OWN - NLM
STAT- MEDLINE
DCOM- 20080326
LR  - 20080319
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Linking)
VI  - 83
IP  - 4
DP  - 2008 Apr
TI  - Assessing abuse liability during drug development: changing standards and 
      expectations.
PG  - 622-6
LID - 10.1038/sj.clpt.6100492 [doi]
AB  - 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.
FAU - Schoedel, K A
AU  - Schoedel KA
AD  - Clinical Pharmacology Group, DecisionLine Clinical Research Corporation, Toronto, 
      Ontario, Canada. k.schoedel@dlcrc.com
FAU - Sellers, E M
AU  - Sellers EM
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20080123
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Central Nervous System Depressants)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Psychotropic Drugs)
SB  - IM
MH  - Canada
MH  - Central Nervous System Depressants/adverse effects
MH  - Central Nervous System Stimulants/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - *Drug Design
MH  - Drug and Narcotic Control/*legislation & jurisprudence
MH  - European Union
MH  - Humans
MH  - Psychotropic Drugs/*adverse effects
MH  - Substance-Related Disorders/*etiology
MH  - Time Factors
MH  - United States
MH  - United States Food and Drug Administration
RF  - 30
EDAT- 2008/01/24 09:00
MHDA- 2008/03/28 09:00
CRDT- 2008/01/24 09:00
PHST- 2008/01/24 09:00 [pubmed]
PHST- 2008/03/28 09:00 [medline]
PHST- 2008/01/24 09:00 [entrez]
AID - 6100492 [pii]
AID - 10.1038/sj.clpt.6100492 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2008 Apr;83(4):622-6. doi: 10.1038/sj.clpt.6100492. Epub 
      2008 Jan 23.