Principles Of Abuseliability Testing

Based on extensive research undertaken over the past several decades, some important general principles governing abuse-liability testing with humans have been established. In the first instance, for example, a meaningful assessment requires that the test drug be compared with a drug of known abuse liability to provide a standard for evaluation. Second, the assessment procedure must involve the indicated comparison over a range of doses of both the test drug and the standard drug of abuse. This permits both a quantitative and a qualitative comparison of the drugs, while guarding against the possibility of overlooking some unique high- or low-dose effects. Third, the testing procedures should include measures of drug effects in addition to those like drug taking in the lab, which directly predict the likelihood of abuse. With these additional measures, it is often possible to obtain reliable estimates of abuse liability by comparing test drugs with a drug of abuse across a range of effects as a standard for evaluation. Fourth, confidence in conclusions regarding the abuse liability of a drug compound can be enhanced by utilizing a multiplicity of measures and experimental procedures. This is the case because our present level of knowledge in this area does not permit a firm determination of the best or most valid predictor of the likelihood of abuse. Finally, a population of test subjects with histories of drug use appears to be the most appropriate selection for predicting the likelihood of abuse of a new test drug, since this is the population who might use such a drug in that way.

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