S09: Models for drug abuse and drug depedence liability assessment

Abstract

Drug abuse and drug dependence are problems of great societal concern. For the pharmaceutical industry, drug abuse and dependence liability present issues not only for patients but also for public health. Diversion of prescription drugs from hospitals and pharmacies for unprescribed and illegal use will bring increased restrictions regarding production, distribution and prescription for these drugs. In order to protect public health and reduce dependence potential in patients receiving prescription drugs, new drugs need to be assessed for abuse and dependence liability as mandated in guidelines by regulatory agencies like the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and the Japanese Department of Health Education and Welfare. In the US the Drug Enforcement Administration (DEA) proposes legislation for classifying drugs in various schedules based on their predicted severity to produce abuse and dependence liability. This lecture will describe and discuss models for assessing drug abuse potential in rodents, primates and humans. Drug discrimination and self-administration models in rodents, primates and humans will be described and discussed. In addition, other in vitro and in vivo models signalling the need for further assessment will be described. A strategy for how the models may be used in drug abuse and dependence liability assessment will be suggested.