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Updates on Human Abuse Potential Studies: Challenges and Regulatory Guidelines

 
  January 24, 2024  
     
 
Xtalks, Online
2024-02-28


Discover this groundbreaking webinar delving into the latest insights from the Cross-Company Abuse Liability Council (CCALC) and The Food and Drug Administration (FDA) in drug development and clinical evaluation of human drug abuse and dependence potential. This webinar aims to discuss current knowledge and recent updates on the clinical evaluation of the abuse and dependence potential of drugs. In September 2023, the CCALC, a group of representatives from the industry, held its first face-to-face meeting with members of the Controlled Substances Staff of The FDA since 2018. At this meeting, key opinion leaders discussed nonclinical and clinical assessments, current issues in the design and analysis of these studies and pertinent topics that have emerged based on recent trends in drug development (e.g., hallucinogens). The clinical portion of the meeting discussed a broad range of topics; however, the current webinar will focus on updating attendees on:

1) Discussions relating to the design and statistical analysis of human abuse potential (HAP) studies

2) Challenges related to recording and documenting abuse-related adverse events

3) Regulatory requirements for assessing physical dependence and withdrawal within a clinical program

Read more...

Join this webinar to gain valuable knowledge from the recent CCALC meeting, FDA guidelines, and discussions on advancements in drug development.

Keywords: Drug Development, Clinical Research, Drug Abuse, CRO, Regulatory, FDA Guidance, CNS, Abuse Potential Assessment, Translational Research
 
 
Organized by: Xtalks
Invited Speakers: Dr. Lynn Webster, MD, Executive Vice President, Scientific Affairs, Dr. Vince Clinical Research
Dr. Naama Levy-Cooperman, PhD, Director, Altreos Research Partners
Dr. Kerri Schoedel, PhD, Director, Altreos Research Partners
 
Deadline for Abstracts: 2024-02-28
 
Registration: Free Registration
E-mail: tristan@xtalks.com
 
 
   
 
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