WAYLAND, Mass., Nov. 5, 2018 /PRNewswire/ -- Dr. Ryan Lanier, Ph.D., Associate Director, Consulting Unit at Analgesic Solutions will present "A Systematic Approach to Meeting Regulatory Requirements for Evaluating Potentially Abuse-Related Events in Clinical Trials" at the 5th Annual Human Abuse Liability Testing & Market Access Conference on Tuesday November 6th in Herndon, VA.
Dr. Lanier will describe how the company's Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®) is an integral component of a drug development program and is designed to meet specifications for assessing abuse potential in clinical trials as described in the 2017 Food and Drug Administration (FDA) Guidance for Industry on the Assessment of Abuse Potential of Drugs.
"The MADDERS system provides sponsors with the only standardized, prospective method for meeting regulatory requirements for assessing the abuse potential of drugs in efficacy and safety clinical trials conducted in patient populations", stated Dr. Lanier. MADDERS has been successfully implemented in multiple, large Phase 2 – 4 trials of various Central Nervous System (CNS)-active compounds in adult and pediatric populations and has shown discriminant validity for differentiating between compounds of different pharmacological classes according to their expected abuse potential.
ABOUT MADDERS® System
As of 2017, all investigational drug products with possible CNS activity are required by the FDA to be comprehensively assessed for abuse potential1. The MADDERS system provides a robust assessment of a medication's abuse potential in clinical trials to support appropriate approval, labeling, and scheduling decisions. The MADDERS system is the only standardized system which prospectively and systematically assesses potentially abuse-related events in clinical trials.
ABOUT ANALGESIC SOLUTIONS
Analgesic Solutions, LLC., founded in 2006, is a privately held company that increases the separation between placebo and active treatment in clinical trials through consulting, innovative tools, central statistical monitoring, technology and specialized training. With hundreds of projects completed and ongoing collaborations with regulatory authorities, Analgesic Solutions is the premier choice for mitigating risk associated with measurement error in clinical trials, and the correct scheduling of abuse potential drugs.
1Food and Drug Administration Center for Drug Evaluation and Research (2017). Guidance for Industry: Assessment of Abuse Potential of Drugs (FDA Maryland).
SOURCE Analgesic Solutions
