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http://dx.doi.org/10.4333/KPS.2005.35.6.471

Guideline for Extended Release Oral Dosage Forms : Development, Evaluation, and Application of In Vitro/In Vivo Correlations  

Choi, Sun-Ok (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
Jeong, Sung-Hee (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
Um, So-Young (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
Jung, Seo-Jeong (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
Kim, Joo-Il (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
Kim, Ok-Hee (Drug Metabolism Team, Pharmacological Research Department, National Institute of Toxicological Research, Korea Food and Drug Administration)
Publication Information
Journal of Pharmaceutical Investigation / v.35, no.6, 2005 , pp. 471-481 More about this Journal
Abstract
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 ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. 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, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.
Keywords
Extended release oral dosage forms; In vitro/In vivo correlations (IVIVC); Bioequivalence;
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  • Reference
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