Incorporation of Abuse Potential Assessment into the Development of New Prescription Drugs
| Autor: | Kerri A. Schoedel, Robert S. Mansbach |
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| Rok vydání: | 2015 |
| Předmět: | |
| Zdroj: | Pharmaceutical Medicine. 29:141-153 |
| ISSN: | 1179-1993 1178-2595 |
| Popis: | Prescription drugs with actions in the central nervous system (CNS) can produce effects on mood, perception, cognition, behavior, and brain reward processes that can result in pleasurable intoxication and subsequent drug-seeking behavior, and in some cases can produce physical dependence. Abuse of prescription drugs represents a risk to public health that is typically addressed through prominent warnings in prescribing information and special restrictions governing prescribing and dispensing of controlled substances. The biological basis of drug-induced reinforcement (reward) is well understood, and drugs with known abuse potential are generally categorized as hallucinogens, stimulants, opioid analgesics, dissociative anesthetics (N-methyl-d-aspartate antagonists), cannabinoids, or CNS depressants. A draft guidance document promulgated by the US Food and Drug Administration (FDA) provides explicit recommendations on what studies are needed for a comprehensive, abuse potential assessment program. Before regulatory approval in the USA, new molecular entities with CNS actions are subjected by the FDA to an evaluation that typically includes assessment of chemistry, pharmacology, effects on animal behavior, effects in healthy human volunteers and in patient populations, and a laboratory-based study with subjects specifically recruited for their experiences with the non-medical use of controlled substances. However, as all programs are unique, the exact requirements can vary widely. From this multidisciplinary body of evidence, regulators determine whether or not a drug should be scheduled, to what level of restriction it should be assigned, and whether or not special conditions for risk mitigation need to be instituted post-approval. |
| Databáze: | OpenAIRE |
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