II. Keynote
IV. Preclinical Section
1. Preclinical Strategy for Evaluation of Novel Mechanism Compounds
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2. Unique Challenges in Study Designs
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3. Evaluation of Biologics
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V. Clinical Section
1. Approaches to identify and classify AEs and aberrant behaviors related to abuse, misuse and diversion during clinical drug development
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2. Statistical Considerations for Human Abuse Potential Studies
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3. Assessments of Physical Dependence in Clinical Setting
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VI. Post-Marketing Section
Throckmorton
Slides (in pdf format)
Chakraborty
Calderon
Smith
Kallman
Lerner
Negus
Chen
Cunningham
Sellers
Rusinowitz
Dasgupta
Hudzik & De Zafra
Roland
Arons
Cassidy
Katz
Schoedel
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Advancements in Abuse Potential Assessments
- Building on the FDA Draft Guidance for Industry
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