Development of the Dissolution Test for Dobesilate Calcium Tablets and Acepifylline Tablets |
Park, Chan-Ho
(Hazardous Substances Analysis Division, Gwangju Regional Food and Drug Administration)
Lee, Jin-Ha (Hazardous Substances Analysis Division, Gwangju Regional Food and Drug Administration) Kim, Eun-Jung (Hazardous Substances Analysis Division, Gwangju Regional Food and Drug Administration) Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation) Kim, Young-Ok (National Institute of Food and Drug Safety Evaluation) Kim, Dong-Sup (National Institute of Food and Drug Safety Evaluation) Song, Young-Me (Korea Food and Drug Administration, Bioequivalence Evaluation Divison) Sah, Hong-Kee (College of Pharmacy, Ewha Womans University) Choi, Hoo-Kyun (College of Pharmacy, Chosun University) |
1 | 박상애, 장수현, 정혜윤, 장성재, 강신정, 장승엽, 최보경, 윤미옥, 최돈웅, 김영임, 최현철, 김호정, 김미정, 김희성, 민충식, 백경민 : 의약품 규격의 국제화사업(I), 식품의약품안전청연구보고서, 433 (2003). |
2 | Ansel, H., Allen Jr., L. and Popovich, N. : Pharmaceutical Dosage Forms and Drug Delivery systems (7th ed.), Lippincott Williams & Wilkins, Baltimore (1999). |
3 | 식품의약품안전청 : 식품의약품통계연보 (2005). |
4 | Gudrun, F. : Guideline on dissolution profile comparison. Drug Inform. J. 35, 865 (2001). DOI |
5 | 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). |
6 | 식품의약품안전청 : 경구용의약품의 용출 규격 설정 지침, 대한약전 제9개정 (2007). |
7 | 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 지침, 대한약전 제9개정 (2007). |
8 | 사홍기 : 의약품의 제제동등성 평가(II)-경구용 제제의 제제동등성 평가, 식품의약품안전청연구보고서, 852 (2003). |
9 | 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 (1997). |
10 | 사홍기 : 비교용출시험과 용출규격의 상관성 연구, 식품의약품안전청 용역연구개발사업 (2004). |
11 | 사홍기 : 의약품의 제제동등성평가(III)-경구용 제제의 제제동등성 평가, 식품의약품안전청연구보고서, 2324 (2004). |