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Our scientists, policy experts, researchers and analysts integrate an understanding of the scientific and policy environments, scientific literature and research, data analysis to meet each individual client's needs.
You can meet PinneyAssociates at scientific meetings throughout the year.
Practice Areas
Drug approval and regulation, including scheduling under the U.S. Controlled Substances Act and other conventions, are informed by a comprehensive abuse liability assessment. The Food and Drug Administration (FDA) requires animal and human abuse liability studies as part of the drug application process and the Drug Enforcement Administration often relies heavily upon these studies when making final drug scheduling decisions. The 2010 FDA Draft Guidance on Abuse Potential Assessment makes clear that a broad range of central nervous system drugs will require animal and human abuse liability testing. Findings from abuse liability studies have implications for marketing, communications, risk management, and approval of final product labeling (and thus the timing of product launch).
Pinney Associates scientists include internationally respected leaders in drug abuse liability assessment. During the past 40 years, several of our experts have served the National Institute on Drug Abuse, College on Problems of Drug Dependence, FDA, and pharmaceutical companies, in the development of methods, as well as the design, conduct, and interpretation of abuse liability assessment studies. Members of our team have presented at and otherwise contributed to Advisory Committee meetings, both as Committee members and outside experts on behalf of sponsors.
Through our collaborations with RenaSci and Lifetree Clinical Research®, we can offer comprehensive animal and human abuse liability assessment related services.
Specific services provided by Pinney Associates, in collaboration with RenaSci and Lifetree include:
- Assist in creating complete abuse liability development plans for regulatory submissions to the FDA and European Medicines Agency (EMA)
- Develop, execute, analyze and report on animal and human abuse liability studies
- Develop comprehensive abuse liability reports and recommendations for the US’ Assessment of Abuse Potential and the EU’s Assessment Report on Abuse Liability and Dependence submissions
- Develop recommendations for appropriate post marketing risk management (2009 FDA draft Guidance on Risk Evaluation and Mitigation Strategies) as indicated or required
- Assist sponsors in preparation for meetings with regulatory officials and serve as their outside experts in regulatory meetings