SOURCE: Xtalks

Xtalks Webinars

December 18, 2014 07:05 ET

Understanding the Clinical Assessment of Abuse Potential During CNS Drug Development, New Webinar Presented by Cambridge Cognition, Hosted by Xtalks

TORONTO, ON--(Marketwired - December 18, 2014) - This webinar will discuss the why, when and how of collecting, evaluating and interpreting abuse potential data throughout CNS drug development, including a discussion of the design, analysis and interpretation of human abuse potential studies. The live broadcast takes place on Wednesday, January 14, 2015, at 12pm EST.

The misuse and abuse of prescription drugs has received increasing media and regulatory attention in recent years. Companies developing new molecular entities (NMEs) with CNS activity or abuse-deterrent formulations (ADFs) of drugs with known abuse liability must submit all data relevant to the abuse potential of their drug. But what is meant by 'potential for abuse'? What data must be submitted? When and how are these data collected? This webinar will provide insight into these questions by reviewing the methods involved in collecting abuse potential data during CNS drug development and current regulatory thinking on NMEs and ADFs.

Join Kerri Schoedel, Director and Co-founder of Altreos Research Partners, Inc., as she provides an overview of nonclinical and clinical abuse potential data requirements throughout the CNS product development cycle and a discussion of draft FDA guidances for NMEs (2010) and ADFs (2013).

Dr. Schoedel will then focus on how human abuse potential studies are designed, including a discussion of the subjective and cognitive measures commonly included and related data collection systems.

Analysis and interpretation of human abuse potential studies will be discussed, including challenges and limitations, and differences in approach between NMEs and ADFs.

Attendees of the webinar will leave with a firm understanding of the what, when and how of abuse potential data collection, in order to meet increasingly stringent regulatory requirements for premarket evaluation of CNS products, and for ADFs, the potential for label claims.
Key Discussion Points:

  • Nonclinical and clinical abuse potential data requirements
  • The regulatory landscape
  • Design of human abuse potential studies
  • Review of cognitive measures and data collection systems
  • Approaches to studies of new molecular entities and abuse-deterrent formulations

To learn more about this event visit: Understanding the Clinical Assessment of Abuse Potential during CNS Drug Development

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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