Safety evaluation of biological products in Korea

  • Han, Eui-Sik (Division of Safety Evaluation, Korea Food and Drug Administration)
  • Published : 2003.10.01

Abstract

Biological products are composed of vaccines, antitoxin, blood products, DNA recombinant protein drugs, monoclonal antibody, cell therapy and gene therapy. Biological products are divided into traditional (i.e. recombinant proteins and monoclonal antibodies) and novel biological products (gene and cell therapy) and will require a similar re-evaluation of the approaches taken during each development program.(omitted)

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