Evaluation of dissolution profile similarity – Comparison between the f2, the multivariate statistical distance and the f2 bootstrapping methods
Tài liệu tham khảo
Moore, 1996, Mathematical comparison of dissolution profiles, Pharm. Technol., 20, 64
EMA, Guideline on the Investigation of Bioequivalence, 2010.
FDA, Guidance for Industry – Dissolution Testing of Immediate Release Solid Oral Dosage Forms, 1997.
Shah, 1999, Dissolution profile comparison using similarity factor, f2, Dissolut. Technol., 6, 15, 10.14227/DT060399P15
Yuksel, 2000, Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and – independent methods, Int. J. Pharm., 209, 57, 10.1016/S0378-5173(00)00554-8
Tsong, 1996, Statistical assessment of mean differences between two dissolution data sets, Drug Inform. J., 30, 1105, 10.1177/009286159603000427
Shah, 1998, In vitro dissolution profile comparison – statistics and analysis of the similarity factor, f2, Pharm. Res., 15, 889, 10.1023/A:1011976615750
Krause, 2014, Visualization and communication of pharmacometric models with Berkeley Madonna, CPT Pharm. Syst. Pharmacol., 3, 1
Zhang, 2010, DDSolver: an add-in program for modeling and comparison of drug dissolution profiles, AAPS J., 12, 263, 10.1208/s12248-010-9185-1
Y. Tsong, P. Sathe, V.P. Shah, In vitro dissolution profile comparison, in: Encyclopedia of Biopharmaceutical Statistics, 2003. pp. 456–462.
Hsu, 1998, On the characteristics of the FDAs similarity factor for comparison of drug dissolution, J. Food Drug Anal., 6, 553
Ju, 1997, On the assessment of similarity of drug dissolution profiles—a simulation study, Drug Inform. J., 31, 1273, 10.1177/009286159703100427
Ma, 2000, Assessment of similarity between dissolution profiles, J. Biopharm. Stat., 10, 229, 10.1081/BIP-100101024
Saranadasa, 2005, A multivariate test for similarity of two dissolution profiles, J. Biopharm. Stat., 15, 265, 10.1081/BIP-200049832
Sathe, 1996, In vitro dissolution profile comparison – statistics and analysis model dependent approach, Pharm. Res., 13, 1799, 10.1023/A:1016020822093
Davit, 2013, Expectations of the US-FDA regarding dissolution data in generic drug regulatory submissions, Biopharma-Asia