Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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Guideline for Bioequivalence Studies of Controlled Release Products

서방성 제제의 생물학적동등성시험을 위한 가이드라인

  • 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)
  • 서현옥 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 김소희 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 안미령 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 안충열 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 박혜진 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 오은경 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 이은주 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 김보연 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 김민정 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 우나리 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 서희원 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과) ;
  • 정수연 (식품의약품안전청 의약품안전국 의약품심사부 약효동등성과)
  • Published : 2010.02.20
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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

References

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