Abstract
Recent advances in biotechnology have significantly improved the research and manufacturing capabilities inherent in pharmaceutical development. In particular, recombinant DNA techniques have provided a means of mass production of numerous proteins such as human insulin and growth hormone that are invaluable to the practice of medicine. Similar techniques are being employed to develop vaccines against selected viral and bacterial diseases. Further exploitation of this technology for drug development as well as the possibility of specific gene therapy is envisioned for the future. The rapid availability of these methods has posed unique problems for the pharmaceutical industry, the regulatory agencies, and the academic medical community requiring enhanced communication and cooperation.
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