Principles of Safety Pharmacology

Mary Jeanne Kallman, Kallman, Mary Jeanne

Although laboratories have been conducting scientific evaluations of the abused drugs for many years, preclinical evaluations of the abuse potential of new drugs have been an integral component of new drug applications more recently. The development of a unified testing approach is crucial prior to initiating individual studies to address abuse potential. The core preclinical studies that will be required include a dependence/withdrawal study, an assessment of the discriminative cue produced by the new drug, and an assessment of whether the drug will be self-administered. This discussion is focused on the requirements for drug scheduling recommendations from the FDA and how to conduct the evaluations that will be used to make those recommendations and how to select parameter details such as preclinical species, test doses, test conditions, route of drug administration, comparator compounds, and behavioral test designs recommended.