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KMID : 1142220070020020021
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Regulatory Research on Food, Drug & Cosmetic
2007 Volume.2 No. 2 p.21 ~ p.27
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Drug Safety : Science or Social Issue?
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Shim Chang-Koo
Lee Sun-Hee
Seo Kyung-Won
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Abstract
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In traditional pharmacotherapy, individual differences in drug response have been regarded as insignificant. As a result, most drugs are designed to contain a fixed dose for use by the entire population. The patient must cope with “onesized” medicine rather than a tailored dosage for the individual patient. It is widely recognized that drugs should be “individualized” or “tailored” in terms of dose, dosage form, and dosage regimen, in order to provide the best pharmacotherapy to patients with various pharmacogenetic characteristics. The 21st century is said to be the century of “individualized medicine” by virtue of remarkable progress in pharmacogenetics and pharmacogenomics. Pharmacogenetic profiling, however, must be refined in order to meet the scientific and ethical needs of individualized medicine. So, for the time being, clinical bridging studies are generally requested by regulatory agencies before they accept drugs developed in foreign countries. In this manuscript, the drug safety issue is discussed in association with the concepts of individualized medicine, pharmacogenetics for individualized medicine, clinical bridging studies to evaluate foreign drugs, pharmacogenetic profiling, and the ethical and social issues of pharmacogenomic profiling. The issues of safety and pharmacogenetic profiling are related not only to science but also to ethics and social affairs. If this point is neglected, the realization of the era of individualized medicine could be substantially delayed, and as a result, pharmacotherapy that only utilizes fixed doses would continue. In order to prevent this, care should be taken that the implementation of pharmacogenetic profiling for patients is done in an ethical manner.
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KEYWORD
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individualized medicine, pharmacogenetics, pharmacotherapy, bridging study, safety, science, ethics
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