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Human Abuse Liability

Lifetree Clinical Research® is a global leader in Human Abuse Liability (HAL) research, pioneering new methodologies, study designs, and following through with precise execution, made possible by years of experience with this subject population. As thought leaders, we are committed to understanding the evolving regulatory environment and have regular interaction with the US FDA regarding the abuse liability of drugs in the marketplace and research strategies that may help us to understand the relative risk of abuse before a drug comes to market. We attend the relevant Advisory Panel Meetings and strive to make certain that client programs are aligned with the most current guidance documentation available for consideration in human abuse liability study design and execution, as well as current regulatory thinking on Risk Management.

One of our studies was a key component in a milestone 2008 NDA submission (EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use - CII ). A landmark approval was granted in August 2009 of this first drug product to contain labeling information regarding abuse liability.

Abuse Liability data is now considered a critical piece of information during the NDA review process for most CNS drugs and having clinical data is a significant positive. Any sponsor working in these fields is strongly encouraged to understand the full impact of recent regulatory decisions, including those from Advisory Committees, FDA guidance documents, relevant IMPACT-X publications, etc., and take those factors into careful consideration as early as possible in designing a full clinical development program. Lifetree’s experience in the field and our commitment to maintaining a leadership position means you get the best, the most recent, and the RIGHT thinking. Lifetree has the people, the knowledge and the drive to deliver what you need, when you need it.

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