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NTIS 바로가기藥劑學會誌 = Journal of Korean pharmaceutical sciences, v.34 no.3, 2004년, pp.229 - 254
사홍기 (대구가톨릭대학교 약학대학) , 조미현 (대구가톨릭대학교 약학대학) , 박상애 (식품의약품안전청 의약품평가부) , 윤미옥 (식품의약품안전청 의약품평가부) , 강신정 (식품의약품안전청 의약품평가부)
The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and compositio...
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
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
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)
FDA, Center for Drug Evaluation and Research, Guidance for Industry - Q1A(R2): Stability testing of new drug substances and products, November 2003
ICH Guideline, Q1C: Stability testing for new dosage forms, November 1996
ICH Guideline, Q1D: Bracketing and matrixing designs for stability testing of drug substances and drug products, Febmary 2002
ICH Guideline, Q1E: Evaluation of stability data, February 2003
FDA, Guidance for Industry - Extended release oral dosage forms: Development, evaluation and application of in vitrol in vivo correlations, September 1997
FDA, Center for Drug Evaluation and Research, Guidance for dissolution testing of immediate release solid oral products, August 1997
FDA, Center for Drug Evaluation and Research, Oral extended (controlled) release dosage forms: In vivo bioequivalence and in vitro dissolution testing, September 1993
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
FDA, Center for Drug Evaluadon and Research, Guidance for Industry: Changes to an approved NDA or ANDA, November 1999
FDA, Center for Drug Evaluadon and Research, Guidance for Industry: Changes to an approved NDA or ANDA(revision 1), April 2004
식품의약품안전청 고시 제 2002-62호 '생물학적동등성시험기준' 제 3조 제 4항
일본국립의약품식품위생연구소(National Institute of Health Sciences), Division of Drugs, Guideline for bioequivalence studies for formulation changes of oral solid forms, February 2000
European Commission, Note to Applicants: Guideline on dossier requirements for type IA and type IB notifications, July 2003
European Commission, Note to Applicants: Procedures for marketing authorisation - Chapter 5. Variations, February 2004
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