Guidance for Industry - Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
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Jung, Sung-Hee
(Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Choi, Sun-Ok (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) Um, So-Young (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) Jung, Seo-Jeong (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) Kim, Joo-Il (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) Chung, Soo-Youn (Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration) |
1 | 局所皮膚通用製劑の後發醫藥品のための生物學的同等性試驗 かイドライン,日本國立醫藥品食品銜生硏究折(2003.7.7) |
2 | 局所皮膚讀用製劑の後發醫藥品のための生物學的同等注試驗 かイドライン(Q&A),日本國立醫藥品衰品衛生硏究所(2003) |
3 | 약사관계법령집 (2002) |
4 | 생물학적동등성시험기준, 식품의양품안전청고시 제 2002-60호 (2002. 11. 22.) |
5 | S.O. Choi, S.H, lung, S.Y. Um, S.J lung, J.I. Kim and S.Y. Chung, Guideline for Bioequivalence Studies of GenericProducts for Topical Use, J Kor. Pharm. Sci., 34(4), 333-340. (2004) |
6 | Guidance for illdustry : Topical Dermatologic Corticosteroids : ill vivo Bioequivalence, US FDA (1995. 6. 2) |
7 | J. Tsai, C. Cheng, Y. Tsai, H. Sheu and C. Chou, Evaluation of in vivo bioequivalence methodology for topical clobestasol 17-propionate based on pharmacodynamic medeling using chinese skin, J. Pharm. Sci., 93(1), 207-217 (2004) DOI ScienceOn |
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