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...
This article is featured on The Association of Clinical Research Professionals (ACRP). Bradley D. Vince, DO and Sheldon H. Preskorn, MD discuss the process of developing a new molecular entity (NME) for FDA approval and strategies for establishing early efficacy. Key...
Most drugs are eliminated from the body through some combination of vital organs, such as the small intestine, liver and/or kidneys. The impaired function of either the liver or the kidney can significantly impact a drug’s pharmacokinetics (PK), influencing its...
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