TORONTO, ON--(Marketwired - March 13, 2017) - The aim of this webinar is to evaluate and discuss the methodological approaches outlined in the guidance and highlight several key areas that may warrant further consideration when designing and planning for such studies. Guest speakers are industry leaders in the evaluation of preclinical and clinical abuse and dependence evaluation.
In January 2017, the FDA finalized their guidance for industry reviewing the requirements for the assessment of abuse potential of drugs. As stated in the guidance, drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce specific effects such as euphoria (or other changes in mood), hallucinations and effects consistent with CNS depressants or stimulants.
Unlike the previous draft version, issued in 2010, this guidance also further elaborates on the criteria for evaluating physical dependency and withdrawal symptoms. The guidance lays out the pathway for determining whether or not human abuse potential evaluation assessment will be required and generally recommends that sponsors evaluate this need along with the FDA during the end-of-phase II meeting. Details are provided in the guidance with respect to the division's review of abuse and dependence related data and outlines the process taken to schedule drugs.
The guidance outlines the abuse related data from chemistry and nonclinical studies and details the types of preclinical studies that are commonly used to evaluate abuse and dependence potential. The section on human studies discusses adverse events of special interest and focuses on methods to summarize these key events across a clinical trial program. Human abuse potential studies, studies that evaluate cognition and performance and clinical evaluation of physical dependence are discussed. Lastly the guidance discusses post-marketing and illicit drug abuse data and lists common data sources for such findings.
Join the panel on Thursday, March 30, 2017 for a live session with Dr. Jack Henningfield, Vice President of Research, Health Policy, Abuse Liability at PinneyAssociates, Dr. David Heal, Executive Director at RenaSci Ltd. and Dr. Beatrice Setnik, Vice President of Scientific Affairs at INC Research, Early Phase.
For more information or to register for this free event visit: The FDA Guidance on the Assessment of Abuse Potential of Drug - A Critical Review
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