As a trusted clinical research organization (CRO) with an on site phase 1 clinical pharmacology unit for human abuse potential (HAP) trials, Dr. Vince Clinical Research is relied upon by sponsors to conduct these trials with a high degree of precision and accuracy....
Human Abuse Potential: CSS Interactions
Dr. Vince Clinical Research is a trusted contract research organization (CRO) for human abuse potential (HAP) trials. We understand the importance of early and consistent engagement with the FDA’s Controlled Substance Staff (CSS) to maintain regulatory compliance and...
Human Abuse Potential: Selecting a Positive Control
As a leading contract research organization (CRO) for human abuse potential (HAP) trials, Dr. Vince Clinical Research has expertise in the creation and implementation of positive control groups. By following well-defined protocols, DVCR produces optimized results for...
Summary of Human Abuse Potential Webinar
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...
Human Abuse Potential: Participant Safety
As the leading CRO for Human Abuse Potential (HAP) studies, Dr. Vince Clinical Research has significant operational expertise in the conduct of these complex clinical trials where volunteer safety is paramount. Our clinical safety team is comprised of Advanced...
Statistical Analysis in Human Abuse Potential Studies
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: Pharmacy Considerations
Dr. Vince Clinical Research operates the ideal clinical site for Human Abuse Potential (HAP) studies. One feature of this facility is the on-site cGMP Pharmacy, built to comply with DEA standards, which is required to source the majority of reference or comparator...
Understanding Subjective Outcome Measures in Human Abuse Potential Studies
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: Subjective Ratings
Dr. Vince Clinical Research is the leading clinical research organization for Human Abuse Potential (HAP) studies. These studies rely on subjective ratings from participants who are experienced with the drug class of interest to determine abuse potential. Every HAP...
Human Abuse Potential: Study Design
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...
