참고문헌 (18)

1. FDA, Center for Drug Evaluation and Research, Guidance for Industry - SUPAC-MR: Modified release solid oral dosage forms; Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing and in vivo bioequivalence documentation, September 1997 

2. FDA, Center for Drug Evaluation and Research, Guidance for Industry - Immediate release solid oral dosage forms; Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, November 1995 

3. H. Sah, S.A. Park, M.O. Yun and S.J. Kang, Scrutiny made to SUPAC-IR dealing with postapproval changes in immediate release solid oral dosage forms, J. Kor. Pharm. Sci., 34, 57-71 (2004) 

   원문보기 상세보기

4. M.J. Rathbone, J. Hadgraft and M.S. Roberts (Eds.), Modifled-Release Drug Delivery Technology, Marcel Dekker Inc, New York, NY, USA, pp. 1-996 (2003) 

5. FDA, Center for Drug Evaluation and Research, Guidance for Industry - Q1A(R2): Stability testing of new drug substances and products, November 2003 

6. ICH Guideline, Q1C: Stability testing for new dosage forms, November 1996 

7. ICH Guideline, Q1D: Bracketing and matrixing designs for stability testing of drug substances and drug products, Febmary 2002 

8. ICH Guideline, Q1E: Evaluation of stability data, February 2003 

9. FDA, Guidance for Industry - Extended release oral dosage forms: Development, evaluation and application of in vitrol in vivo correlations, September 1997 

10. FDA, Center for Drug Evaluation and Research, Guidance for dissolution testing of immediate release solid oral products, August 1997 

11. FDA, Center for Drug Evaluation and Research, Oral extended (controlled) release dosage forms: In vivo bioequivalence and in vitro dissolution testing, September 1993 

12. FDA, Center for Drug Evaluadon and Research, Guidance for Industry: SUPAC-IR/MR: Immediate release and modified release solid oral dosage forms; Manufacturing equipment addendum, January 1999 

13. FDA, Center for Drug Evaluadon and Research, Guidance for Industry: Changes to an approved NDA or ANDA, November 1999 

14. FDA, Center for Drug Evaluadon and Research, Guidance for Industry: Changes to an approved NDA or ANDA(revision 1), April 2004 

15. 식품의약품안전청 고시 제 2002-62호 '생물학적동등성시험기준' 제 3조 제 4항 

16. 일본국립의약품식품위생연구소(National Institute of Health Sciences), Division of Drugs, Guideline for bioequivalence studies for formulation changes of oral solid forms, February 2000 

17. European Commission, Note to Applicants: Guideline on dossier requirements for type IA and type IB notifications, July 2003 

18. European Commission, Note to Applicants: Procedures for marketing authorisation - Chapter 5. Variations, February 2004 

저자의 다른 논문 :

사홍기 (5) 조미현 (3) 박상애 (5) 윤미옥 (8) 강신정 (21)