Food-Effect Bioavailability and Fed Bioequivalence Studies |
Choi, Sun-Ok
(Division of Biopharmaceutics, Department of Pharmacology, National Institute of Toxicological Research, Korea Food and Drug Administration)
Jung, Sung-Hee (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 | Guidance for Industry : Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. CDER, US FDA (2003. 3. 19.) |
2 | 후발의약품의 생물학적동등성시험 가이드라인. 의약심 제487호, 일본 (1998. 12. 22) |
3 | Note for Guidance on the Investigation of Bioavailability and Bioequivalence. Committee for Proprietary Medicinal Products, EMEA (2001. 7. 26) |
4 | Guidance for Industry : SUPAC-IR : Immediate Release Solid Oral Dosage Forms : Scale-Up and Post-Approval Changes :Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. CDER, US FDA (1995. 11.) |
5 | Guidance for Industry : SUPAC-MR : Modified Release Solid Oral Dosage Forms : Scale-Up and Post-Approval Changes :Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. CDER, US FDA (1997. 10. 6.) |
6 | Guidance for Industry : Statistical Approaches to Establishing Bioequivalence. CDER, US FDA (2001. 2.) |
7 | 생물학적동등성시험기준,식품와약품안전청고시 제 2002-60호 (2002. 11. 22.) |
8 | Conduct and Analysis of Bioavailability & Bioequivalence Studies Part A : Oral Dosage Formulations Used for Systemic Effects. Health Canada, Canada (1992) |
9 | Conduct and Analysis of Bioavailability & Bioequivalence Studies Part B : Oral Modified Release Formulations. Health Canada, Canada (1996) |
10 | 안전성·유효성심사에 관한 규정 (식품의악품안전청고시 제2003-17호, 2003. 4. 14.) |
11 | 약사관계법령집 (2002) |
12 | Guidance for Industry; Food-Effect Bioavailibility and Fed Bioequivalence Studies. CDER, US FDA (2002. 12.) |
13 | Guidance for Industry : Waiver of In Vivo Bioavailibility and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. CDER, US FDA (2000. 8.) |