Advancements in Abuse Potential Assessments 
- Building on the FDA Draft Guidance for Industry

Slides (in pdf format)

 


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