Pharmaceutical Regulatory Affairs: Open Access

Zachary J Zimmermann

Publications

• Review Article
  Conducting Preclinical Abuse Liability Screening in Only One Sex: Making a Case for “Reasonable Exclusion”
  Author(s): David V Gauvin and Zachary J ZimmermannDavid V Gauvin and Zachary J Zimmermann
  
  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 requ.. Read More»
  DOI: 10.4172/2167-7689.1000180

  Abstract PDF