Abstract
Purpose: To review current knowledge of the state of the models of abuse potential from the perspective of pharmaceutical drug development and to demonstrate how the models are applicable.
Intended Audience: Pharmaceutical companies, researchers, policymakers, and all others who engage in areas of drug development and drug abuse issues.
Summary: An overview of the current literature on models of abuse potential in human and animal models.
Contribution to the Field: This textbook identifies the current literature of abuse potential and extends the literature to applicable models of abuse of new pharmaceuticals in order to identify the potential for abuse.
Main Sections: This text has several main sections which include rodent and primate models, preclinical screening models, liability, risk management, and regulatory framework. Each section includes a detailed introduction, followed by historic and current literature on the topic.
Review: The authors have provided a detailed text on nonclinical assessments of abuse potential in pharmaceuticals, which are new to the market. It is scholarly and original work which discusses the basic framework of the potential for drug abuse. What makes it even more interesting is that it adds to the current discussion on drug abuse potential by discussing new pharmaceuticals, which have not been discussed in detail in previous literature.
The sections that are under Assessing Physical Dependence provide an extensive review of the definitions of dependence, as well as explanations of withdrawal through the use of animal models. They further discuss good laboratory practices and regulatory guidance. This section could easily be a primer for anyone unfamiliar with dependence and withdrawal and lays a solid foundation of these topics.
The sections under Clinical Evaluation of Abuse Potential for New Pharmaceuticals provide a perceptive and rigorous template for anyone who may conduct an abuse potential trial. Researchers, students, and pharmaceutical companies would benefit from this knowledge as it lays the framework for any future studies of abuse potential. The authors provided an excellent table, which discusses the FDA’s abuse-related adverse event terms.
Nonclinical Assessment of Abuse Potential for New Pharmaceuticals has accomplished its goal in providing industry and regulatory scientists with well-described and long-established models. It also provides excellent scholarly information on how to mitigate the potential for abuse among humans when evaluating new pharmaceuticals. This would definitely be a helpful text for not only researchers but clinicians who wish to understand how models of abuse are analyzed.
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