alexa Abstract | Assessment of Dependence Liability of New Molecular Entities under the Current FDA Draft Guidance Document: Seeking Best Practices
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Abstract

In a recent series of unprecedented collaborative meetings between U.S. FDA members of the controlled substances staff (CSS) within the center for drug evaluation and research (CDER) and the pharmaceutical industry (pharmaceutical research and manufacturers association–PhRMA) members have delineated a “standard” for conducting preclinical abuse liability screening of all new molecular entities that affect the CNS. We argue for a “mind shift” in policies and methodologies used to quantify the potential discontinuation syndrome that may be engendered following abrupt cessation of repeated dose administrations of all New Molecular Entities under this new model. We argue against the use of the current “fixed dose” strategy to the more informative “escalating dose” or “equivalent dose” strategies that more accurately predicts the dependence potential of drug substances regardless of expected therapeutic doses.

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Author(s): David VG, Zachary JZ and Theodore JB

Keywords

Drug dependence,Dependence liability, Abuse liability,testing, Preclinical development, Discontinuation syndrome, Methods, Review, US FDA guidelines,Regulatory affairs,Pharmaceutical ethics,Regulatory compliance

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