Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Scott E Boley


  • Review Article
    Rx: Observe, Do not Treat When is it Appropriate not to Treat?
    Author(s): David V Gauvin and Scott E BoleyDavid V Gauvin and Scott E Boley

    Development of a protocol for a nonclinical safety study to evaluate the safety profile of an investigational therapeutic, whether it is a toxicology or safety pharmacology study, must not be conducted in haste. The evaluation of this novel therapeutics relies on the integrated strategy developed by the scientific team, which may include the pharmaceutical company and the services of a contract research organization. All nonclinical study protocols involving the use of live animals require the inclusion of the Institutional Animal Care and Use Committee (IACUC) and staff veterinarians during the review of the study protocol. The team, as a whole, must endure a frank, honest, and open discussion regarding study design and animal welfare issues. All available information regarding the test material should be shared with all parties in a manner and time that allows for constructive proto.. Read More»
    DOI: 10.4172/2167-7689.1000195

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