Written by Lynn Webster, MD, Executive Vice President, Scientific Affairs, Dr. Vince Clinical Research Last week, the FDA released draft guidance to accelerate the development of non-opioid treatments for chronic pain. This is not just a regulatory update—it reflects...
The Cross-Company Abuse Liability Council (CCALC) meeting held in Washington, DC, covered several themes related to the evaluation of abuse potential, including behavioral economics, physical dependence, and adverse events (AEs); the discussion convened experts from...
For centrally acting drugs, understanding abuse potential is crucial for public health and regulatory decision-making. The U.S. Food and Drug Administration (FDA) provides detailed guidelines on assessing abuse potential through its guidance, Assessment of Abuse...
Human abuse potential (HAP) studies play a crucial role in evaluating the safety and risks of new medications with psychoactive properties. These studies help determine the likelihood that a drug might be abused recreationally, which is an important component for...
Human abuse potential (HAP) clinical studies are important components of the risk assessment for centrally-acting drugs, particularly those with psychoactive effects of interest, such as mood-elevating, stimulant, sedative, or hallucinogenic effects. Study Objectives...
When it comes to clinical studies, particularly those examining human abuse potential (HAP), the way participants are selected and recruited is crucial. These studies are designed to evaluate whether a substance, such as a new medication or drug, has the potential to...
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