alexa Conducting Preclinical Abuse Liability Screening in Only One Sex: Making a Case for and#8220;Reasonable Exclusionand#8221; | OMICS International | Abstract
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

Conducting Preclinical Abuse Liability Screening in Only One Sex: Making a Case for “Reasonable Exclusion”

David V Gauvin1* and Zachary J Zimmermann1,2

1Department of Neurobehavioral Sciences, MPI Research, Mattawan, USA

2Department of Psychology, Western Michigan University, Kalamazoo, Michigan, USA

*Corresponding Author:
David V Gauvin
Department of Neurobehavioral Sciences, MPI Research
54943 North Main Street, Mattawan, MI 49071, USA
Tel: +1 269-668-3336
E-mail: [email protected]

Received date: January 11, 2017; Accepted date: January 16, 2017; Published date: January 24, 2017

Citation: Gauvin DV, Zimmermann ZJ (2017) Conducting Preclinical Abuse Liability Screening in Only One Sex: Making a Case for “Reasonable Exclusion”. Pharm Regul Aff 6:180. doi:10.4172/2167-7689.1000180

Copyright: © 2017 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

The Animal Welfare Act (AWA; 1990) requires the reduction in use of purpose bred animal subjects in bona fide research conducted in drug development. The National Institutes of Health (NIH) Revitalization Act of 1993 also requires its Director to reduce the number of animals used in government funded research as well as promoting those specific study protocols that provide valid and reliable data using only one gender. The consensus between the pharmaceutical industry and FDA was that a valid and reliable set of abuse liability studies did NOT require the inclusion of both male and female subjects. In recent pre-study protocol reviews, FDA has required the inclusion of both males and female animals in all three core abuse liability assays, basically doubling the total number of animals used on a single study design. NIH/FDA policy does allow for exceptions to the new rule. We provide evidence to establish a defence of a more balanced approach to these study designs that complies with the AWA and the NIH Revitalization Act by reducing the use of laboratory animals in preclinical research and to align the study designs with current goals of the International Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).

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