Abuse Liability of Drugs: Testing in Humans
There is probably no drug used to treat illness that does not also pose certain risks. One such risk, generally limited to drugs that have actions on the central nervous system, is that the drug will be misused or abused because of these effects. Drugs such as these are said to have abuse potential or abuse liability. If the drugs have important therapeutic use, they may still be made available, but they will be subject to certain legal controls under various federal and state laws (see CONTROLLED SUBSTANCES ACT). Over the past fifty years, a number of methods have been developed to test new drugs to determine their abuse liability, so that both the public and the medical profession can be warnedabout the needfor appropriate caution when using certain drugs. These methods involve both testing in animals (preclinical) and testing in humans (clinical).
Several important reasons exist for why testing with humans is useful and necessary in the development of safer and more effective pharmacological agents. The research on laboratory animals demonstrating greater or lesser degrees of the abuse liability of drugs must be validated with humans; this reduces the likelihood of error in assessing potential risks.
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