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  1. Regulatory considerations for nucleic acid vaccines.

    Article, Communication - En anglais

    WHO meeting on nucleic acid vaccines. Geneva CHE, 1994/05/17.

    For regulatory purposes nucleic acid vaccines are considered biological products and will be regulated by the Center for Biologics Evaluation and Research (CBER).

    Vaccines derived through the use of this technology may ultimately find broad application as preventive vaccines for infectious disease or as therapeutic vaccines for treatment of disease.

    The regulations that govern the use of biological products as well as other guidance documents available from CBER are applicable to the regulation of nucleic acid vaccines.

    Mots-clés Pascal : Acide nucléique, Vaccin, Etats Unis, Réglementation, Activité biologique, Sécurité, Essai préclinique, Toxicité, Amérique du Nord, Amérique

    Mots-clés Pascal anglais : Nucleic acid, Vaccine, United States, Regulation, Biological activity, Safety, Preclinical trial, Toxicity, North America, America

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 95-0087724

    Code Inist : 002A31D01C2. Création : 09/06/1995.