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KMID : 0369820050350060471
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Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 6 p.471 ~ p.481
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Guideline for Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
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최선옥/Choi SO
정성희/엄소영/정서정/김주일/김옥희 /Jung SH/Um SY/Jung SJ/Kim JI/Kim OH
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Abstract
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In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ┌Guidanceforbioequivalencetest┘. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ┌Extendedreleaseoraldosageforms:development,evaluation,andapplicationofinvitro/invivocorrelations┘ will be helpful for us to make our own guideline.
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KEYWORD
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Extended release oral dosage forms, In vitro/In vivo correlations, IVIVC, Bioequivalence
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