Protecting vulnerable populations from abusing new CNS active drugs
Understanding the role of the Human Abuse Potential Assessment in clinical drug development

Pharmaceutical companies developing new drugs that cross the blood-brain barrier face challenges in demonstrating safety.


With awareness of the impact from drug abuse, regulators closely examine the chemistry, pharmacology and safety data of new drugs in forming recommendations.


This paper discusses the importance of the Human Abuse Potential study in assessing abuse potential through the evaluation of cognition and performance, abuse related AEs from clinical studies and human physical dependence studies. Furthermore, this paper outlines when a HAP study is appropriate and when it should be conducted as well as protecting vulnerable populations.



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