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KMID : 0369820040340040333
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 4 p.333 ~ p.340
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Guideline for Bioequivalence Studies of Generic Products for Topical Use
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최선옥/Choi SO
정성희/엄소영/정서정/김주일/정수연/Jung SH/Um SY/Jung SJ/Kim JI/Chung SY
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Abstract
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A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.
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KEYWORD
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Topical drug, Bioequivalence
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