alexa Assessment of Dependence Liability of New Molecular Ent
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

Assessment of Dependence Liability of New Molecular Entities under the Current FDA Draft Guidance Document: Seeking Best Practices

Gauvin DV*, Zimmermann ZJ and Baird TJ

MPI Research, Neurobehavioral Sciences Division, 54943 North Main Street, Mattawan, MI USA

Corresponding Author:
Gauvin DV
Neurobehavioral Sciences Division
MPI Research
54943 North Main Street
Mattawan, MI USA
Tel: +1 269-668-3336 X 1613
Fax: +1 269-668-4151
E-mail: [email protected]

Received: January 18, 2016 Accepted: January 20, 2016 Published: January 29, 2016

Citation: Guavin DV, Zimmermann ZJ, Baird TJ (2016) Assessment of Dependence Liability of New Molecular Entities under the Current FDA Draft Guidance Document: “Seeking Best Practices”. Pharmaceut Reg Affairs 5:158. doi: 10.4172/2167-7689.1000158

Copyright: © Gauvin DV, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

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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