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Best Practice brings together the premier experts in designing and implementing studies of abuse liability in animal models and human studies. We have worked with companies in preparing the project reports and summary materials for the FDA; and, we have participated with companies in presentations to the Controlled Substance staff at the Agency.
Several factors dictate whether or not the FDA will require detailed preclinical and clinical studies of abuse liability before granting drug approval, including:
- The receptor binding characteristics of a new drug,
- The drug's effects on the electrophysiology of the brain reward system,
- In vivo microdialysis measurements of dopamine in nucleus accumbens, and
- The planned clinical indication.
Preclinical studies of abuse liability generally include animal trials to determine intravenous drug self administration versus placebo; drug discrimination versus placebo and a comparator drug; and the development of physical dependence and tolerance. In cases where the preclinical data suggest a risk of drug abuse/dependence, sponsors are obliged to examine abuse liability in standardized human laboratory studies. These studies generally compare the test compound against placebo and a positive control in a population of polydrug abusers. It is important for a sponsor to present an integrated picture of preclinical and clinical laboratory studies of abuse liability, because of the possibility of false positives in any single paradigm or study.
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