The basis of regulation of medicines is an assessment of risk and benefit. As the process of drug development has evolved with the advances in scientific knowledge, new and more precise methods of measuring drug efficacy have been created. Pharmacovigilance must also change with as much emphasis being placed on demonstrating the safety of a medicine as on preventing harm. Communication of these issues to interested parties remains problematical with room for considerable improvement. Copyright (C) 2003 John Wiley Sons, Ltd.
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Pfizer Global Res & Dev, Sandwich Labs, Strateg Management, Sandwich, Kent, EnglandPfizer Global Res & Dev, Sandwich Labs, Strateg Management, Sandwich, Kent, England
Schmid, Esther F.
Smith, Dennis A.
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机构:Pfizer Global Res & Dev, Sandwich Labs, Strateg Management, Sandwich, Kent, England
Smith, Dennis A.
Ryder, Steven W.
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机构:Pfizer Global Res & Dev, Sandwich Labs, Strateg Management, Sandwich, Kent, England
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Univ Calif Los Angeles, Sch Publ Hlth, Dept Community Hlth Sci, Los Angeles, CA 90095 USAUniv Calif Los Angeles, Sch Publ Hlth, Dept Community Hlth Sci, Los Angeles, CA 90095 USA