Abuse potential assessment
- Abuse potential assessments (also referred to as the Controlled Substances Act 8-Factor Analysis) for regulatory submissions
- Preliminary abuse potential assessment to determine strengths, weaknesses, and gaps in the abuse potential assessment program
- Expert opinion and due diligence on probable scheduling and identification of factors that will likely affect scheduling
- Expert evaluation of animal and human abuse potential studies
- Assist in creating complete abuse potential development plans for regulatory submissions to the FDA, EMA, and other regulatory agencies
- Develop, analyze, and report on animal and human abuse potential studies, in collaboration with RenaSci and other study providers
- Develop comprehensive abuse potential assessment reports with scheduling recommendations
- Prepare sponsors for meetings with regulators and serve as outside experts in regulatory meetings
- Data Management and Statistical Analysis
- Clinical Pharmacology
- Regulatory and Health Policy
- Integrated Strategic Communications
Value to our clients
PinneyAssociates includes internationally respected leaders in the assessment of drug abuse potential. During the past 40 years, our experts have served the National Institute on Drug Abuse, College on Problems of Drug Dependence, the FDA, and pharmaceutical companies in the development of methods, as well as the design, conduct, and interpretation of abuse potential assessment studies.
Our comprehensive abuse potential assessments of CNS active drugs have helped our clients achieve appropriate scheduling under the U.S. Controlled Substances Act and international drug control conventions. Clients rely on our assessments to inform their drug development programs.