Development of the Dissolution Test for Viquidil Hydrochloride Capsules and Alibendol Tablets |
Hwang, Joung-Boon
(Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division)
Koo, Eun-Joo (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Go, Seu-Youn (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Cho, Kyung-Chul (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Moon, Hyun-Ju (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Cho, Soo-Yeul (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Kang, Chan-Soon (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Shon, Yeo-Won (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) Kim, Young-Ok (National Institute of Food and Drug Safety Evaluation, Scientific Drug Evaluation and Research Division) Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Scientific Drug Evaluation and Research Division) Cho, Dae-Hyun (Gyeongin Regional Food and Drug Administration, Hazardous Substances Analysis Division) |
1 | 식품의약품안전청 통계연보 (2005). |
2 | Gudrun, F. : Drug Inform. J. 35, 865 (2001). |
3 | Food and Drug Administration : Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. US department of health and human services/Food and drug administration/Center for drug evaluation and research, Rockville MD (1997). |
4 | 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 지침. 대한약전 제 9 개정. |
5 | 식품의약품안전청 : 경구용의약품의 용출 규격 설정 지침. 대한약전 제 9 개정. |
6 | 식품의약품안전청 용역연구개발사업 : 의약품의 제제동등성평가(III)-경구용 제제의 제제동등성 평가 사홍기 (2004). |
7 | FDA, Center for Drug Evaluation and Research, Guidance for Industry-Extended release oral dosage forms : development, evaluation and application of in vitro/in vivo correlation. September (1997). |
8 | 식품의약품안전청 용역연구개발사업 : 비교용출시험과 용출규격의 상관성 연구. 사홍기 (2004). |
9 | 식품의약품안전청 용역연구개발사업 : 의약품의 제제동등성평가(II)-경구용 제제의 제제동등성 평가. 사홍기 (2003). |
10 | 식품의약품안전청 연구개발사업 : 의약품 규격의 국제화사업(I). 박상애 등 (2003). |
11 | Ansel, H., Allen Jr. L. and Popovich, N. : Pharmaceutical Dosage Forms and Drug Delivery systems (7th ed.), Lippincott Williams & Wilkins, Baltimore (1999). |