Determining if a HAP or ADF Assessment is Needed

Investigating the Abuse Potential of your CNS-Active Therapeutic

The FDA Guidance, Assessment of Abuse Potential of Drugs, states:

Drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential…

The results of a human abuse potential (HAP) trial can indicate that your product will need an abuse-deterrent formulation (ADF), or specific labelling. Altasciences’ scientific, regulatory, and clinical experts will work with you to design a roadmap for your HAP evaluation program.

HAP trials are procedurally intense, requiring high levels of skill and experience, secure clinical facilities with the necessary licenses, and pharmacy capabilities and expertise to ensure appropriate handling and storage of the drug products.

For a more in-depth look at the requirements and implications of HAP trials for your drug development program, consult The Altascientist — Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs.

Speak with an expert today for more information or to review your specific program requirements.

Related Resources:

Webinar: To Control or be Controlled – Navigating the Abuse Potential Evaluation of CNS-Active Drugs for EU and US Submissions

Scientific Poster: Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials

Webpage: Human Abuse Potential

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

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We Deliver Your Projects On-Time.

On-Time Delivery

Over the last 12 months, our project management team has played a key role in achieving a 99% on-time delivery success rate on your primary KPIs.

Altasciences’ high-quality project management is key to the success of your drug development programs, and is an integral part of our service offering. Our project management team has extensive expertise in managing studies for a wide range of therapeutic areas in small and large molecules, and will oversee every aspect of your study.

Partner with us to ensure seamless and timely communication for the successful completion of your project.

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Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

Which Dosage Form Gets Your Drug to Market Faster?

Liquid-Filled Capsules ― Getting Your Drug to Market, Fast

Altasciences has developed and manufactured practically every dosage form on the market, and our experts agree that liquid-filled, two-piece, hard-shell capsules (LFCs) offer several advantages over other solid dosage forms, such as ease of scalability and manufacturing, faster absorption, simpler packaging, and excellent product stability.

With LFCs, scientists can effectively formulate poorly soluble drugs, while reducing development time and costs.

Watch our Executive Vice President of Operations, Ben Reed, explain in more detail.