Pharmaceutical Regulatory Affairs: Open Access

Baird TJ

Publications

• Review Article
  Assessment of Dependence Liability of New Molecular Entities under the Current FDA Draft Guidance Document: “Seeking Best Practices”
  Author(s): Gauvin DV, Zimmermann ZJ and Baird TJGauvin DV, Zimmermann ZJ and Baird TJ
  
  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 .. Read More»
  DOI: 10.4172/2167-7689.1000158

  Abstract PDF