REFERENCES
- , Federal Register, Vol. 60; 61638–61643, 1995.
- , Federal Register, Vol. 65; 64449, 2000.
- Moore J.W., Flanner H.H. Mathematical Comparison of Curves with an Emphasis on In Vitro Dissolution Profiles. Pharm. Technol. 1996; 20(6)64–74
- Polli J.E., Rekhi G.S., Augsburger L.L., Shah V.P. Methods to Compare Dissolution Profiles and a Rationale for Wide Dissolution Specifications for Metoprolol Tartrate Tablets. J. Pharm. Sci. 1997; 86(6)690–700
- Pillay V., Fassihi R. Evaluation and Comparison of Dissolution Data Derived from Different Modified Release Dosage Forms: An Alternative Method. J. Control. Release 1998; 55(1)45–55
- Anderson N.H., Bauer M., Boussac N., Khan-Malek R., Munden P., Sardaro M. An Evaluation of Fit Factors and Dissolution Efficiency for the Comparison of In Vitro Dissolution Profiles. J. Pharm. Biomed. Anal. 1998; 17(4–5)811–822
- Sathe P.M., Tsong Y., Shah V.P. In-Vitro Dissolution Profile Comparison: Statistics and Analysis, Model Dependent Approach. Pharm. Res. 1996; 13(12)1799–1803
- Costa P., Lobo J.M.S. Modeling and Comparison of Dissolution Profiles. Eur. J. Pharm. Sci. 2001; 13(2)123–133
- Marston S.A., Polli J.E. Evaluation of Direct Curve Comparison Metrics Applied to Pharmacokinetic Profiles and Relative Bioavailability and Bioequivalence. Pharm. Res. 1997; 14: 1363–1369
- Polli J.E., McLean A.M. Novel Direct Curve Comparison Metrics for Bioequivalence. Pharm. Res. 2001; 18: 734–741
- Rekhi G.S., Eddington N.E., Fossler M.J., Schwartz P., Lesko L.J., Augsburger L.L. Evaluation of In Vitro Release Rate and In Vivo Absorption Characteristics of Four Metoprolol Tartrate Immediate-Release Tablet Formulations. Pharm. Dev. Technol. 1997; 2: 11–24