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http://dx.doi.org/10.4333/KPS.2010.40.1.063

Guideline for Bioequivalence Studies of Controlled Release Products  

Seo, Hyun-Ok (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Kim, So-Hee (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Ahn, Mee-Ryung (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Ahn, Choong-Yul (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Park, Hye-Jin (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Oh, Eun-Kyung (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Lee, Eun-Ju (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Kim, Bo-Yeon (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Kim, Min-Jeong (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Woo, Na-Ry (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Seo, Hee-Won (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Chung, Soo-Youn (Bioequivalence Evaluation Division, Drug Evaluation Department, Pharmaceutical Safety Bureau, Korea Food and Drug Administration)
Publication Information
Journal of Pharmaceutical Investigation / v.40, no.1, 2010 , pp. 63-66 More about this Journal
Abstract
The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.
Keywords
Bioequivalence study; Controlled-release product; Bioequivalence study under fed condition;
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