title: Appropriate experimental approaches for predicting abuse potential and addictive qualities in preclinical drug discovery.
abstract: BACKGROUND
  Drug abuse is an increasing social and public health issue, putting the onus on drug developers and regulatory agencies to ensure that the abuse potential of novel drugs is adequately assessed prior to product launch.
  
  
  METHODS
  This review summarizes the core preclinical data that frequently contribute to building an understanding of abuse potential for a new molecular entity, in addition to highlighting models that can provide increased resolution regarding the level of risk. Second, an important distinction between abuse potential and addiction potential is drawn, with comments on how preclinical models can inform on each.
  
  
  CONCLUSIONS
  While the currently adopted preclinical models possess strong predictive validity, there are areas for future refinement and research. These areas include a more refined use of self-administration models to assess relative reinforcement; and the need for open innovation in pursuing improvements. There is also the need for careful scientifically driven application of models rather than a standardization of methodologies, and the need to explore the opportunities that may exist for enhancing the value of physical dependence and withdrawal studies by focusing on withdrawal-induced drug seeking, rather than broad symptomology.
authors.affiliation: Global Safety Pharmacology, Drug Safety Research and Development, Pfizer Worldwide Research and Development , Eastern Point Road, MS 8274-1232, Groton, CT 06340 , USA andy.mead@pfizer.com.
authors.forename: Andy N
authors.initials: AN
authors.lastname: Mead
mesh_terms: D000818:Animals; D016739:Behavior, Addictive; D004192:Discrimination, Psychological; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D006801:Humans; D012054:Reinforcement, Psychology; D012646:Self Administration; D013375:Substance Withdrawal Syndrome; D019966:Substance-Related Disorders / Q000503:physiopathology / Q000523:psychology
keywords: abuse potential; addiction; animal models; behavior; drug abuse; drug discrimination; neurophysiology; reinforcement; reward; self-administration