Human Abuse Liability (HAL)

Human abuse liability (HAL) data are critical pieces of information during the new drug application (NDA) review process for most treatments that involve central nervous system (CNS) indications and abuse-deterrent properties. The 2010 FDA draft guidance, “Assessment of Abuse Potential of Drugs,” states that a broad range of CNS drugs requires HAL testing.  

The HAL experts at PRA Health Sciences work with clients who are developing CNS compounds to incorporate critical regulatory decisions and requirements as early as possible into their clinical development programs. We understand that findings from abuse liability studies have implications for marketing, communications, risk management, and final product approval. For many years, our expert teams in the United States (US) have delivered comprehensive HAL services and provided clients with the innovative solutions necessary to fully test their products.