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KMID : 1142220090040010081
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Regulatory Research on Food, Drug & Cosmetic
2009 Volume.4 No. 1 p.81 ~ p.97
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Unification of Drug Equivalence Criteria
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Kim Yong-Hee
Lee Yong-Bok
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Abstract
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Korea Food and Drug Administration (KFDA) has made it an obligation to submit bioequivalence test data for the generic drug permission from 1989. In 1999, bioequivalence test as well as comparative dissolution test was adopted as the method of drug equivalence in relation to the alternative preparation for prescribed preparation. And in Aug. 2001, the alternative preparation for prescribed preparation with the bioequivalence -approved product became possible by revising the pharmaceutical affairs law. Since then, social concern for drug equivalence was risen. However, there are a lot of needs for the sake of peaple's convenience, for the unification of notice, laws and ordinances. In this study, we prepared unified proposition about drug equivalence and bioequivalence based on the comparison of associated guidelines as a part of solving these problems.
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KEYWORD
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Drug equivalence test, Bioequivalence test
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