Press Release (ePRNews.com) - TORONTO - Jun 21, 2018 - This second live webinar in a two-part series will provide a complementary overview of the requirements for the conduct of Human Abuse Potential assessment and clinical abuse potential data integration into the regulatory framework of an 8-Factor Analysis. The session will include a discussion of recent experience and regulatory interactions with the FDA, along with information on submitting an abuse potential assessment and the needed components of a full development plan, details on design, analysis, and interpretation of human abuse liability studies. Featured speakers will outline the principals and issues involved in the design, analysis, and interpretation of clinical abuse potential studies and discuss the potential for the Take Drug Again subjective response to serve as a primary endpoint in HAP studies.
This webinar upcoming on Tuesday, July 10, 2018, at 10 a.m. EDT (3 p.m. BST/UK), will have the following learning objectives:
- Outlining the principles and issues involved in the design, analysis, and interpretation of clinical abuse potential studies
- Consider timing and strategy of the assessment of human abuse potential in order to satisfy regulatory requirements/expectations
- Understand the integration of clinical data in the 8-Factor Analysis/Modular Abuse Potential submission to FDA
Topics will include:
- Determining a drug’s abuse potential
- When Should an Abuse Potential Assessment be submitted to FDA?
- What should be included in an Abuse Potential Submission?
- Human laboratory studies
- Human abuse potential study in recreational drug users
- Related pharmacology studies
- Clinical trial data relative to Abuse Potential Assessments
- Labeling and drug scheduling
- Discuss the potential of the Take Drug Again endpoint as a primary endpoint in Human Abuse Potential
- FDA 8-Factor Analysis/Modular Abuse Potential Submission to FDA in NDA
Join Lynn R. Webster, MD, Vice President of Scientific Affairs, Neurosciences at PRA Health Sciences, Ryan Turncliff, PhD, Sr. Director of Scientific Affairs, Clinical Pharmacology at PRA Health Sciences and Jack Henningfield, PhD, Vice President of Research, Health Policy, and Abuse Liability at PinneyAssociates, for an insightful and interactive discussion.
For more information about this complimentary webinar visit: Crossing the Blood-Brain Barrier – The Human Element of Abuse Potential Assessment.
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