A gamma process modeling approach for the comparison of dissolution profiles

References

• Eaton ML, Muirhead RJ, Steeno GS. Aspects of the dissolution profile testing problem. Biopharm Rep. 2003;11:2–7.
   Google Scholar
• Polli JE, Rekhi GS, Augsburger LL, et al. Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartate tablets. J Pharm Sci. 1997;86:690–700.
   PubMed Web of Science ®Google Scholar
• Sathe P, Tsong Y, Shah VP. In-vitro dissolution profile comparison: statistics and analysis, model dependent approach. Pharm Res. 1996;13:1799–1803.
   PubMed Web of Science ®Google Scholar
• Sathe P, Tsong Y, Shah VP. In vitro dissolution profile comparison and IVIVR: carbamazepine case. In: Young D, Devane JD, Butler J, editors. In vitro-in vivo correlations. New York (NY): Plenum Publishing; 1996. p. 31–42.
   Google Scholar
• Shah VP, Lesko LJ, Fan J, et al. FDA guidance for industry: dissolution testing of immediate release solid oral dosage forms. Dissolut Technol. 1997;4:15–22.
   Google Scholar
• Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol. 1996;20:64–74.
   Google Scholar
• Podczeck F. Comparison of in vitro dissolution profiles by calculating mean dissolution time (MDT) or mean residence time (MRT). Int J Pharm. 1993;97:93–100.
   Web of Science ®Google Scholar
• Shah VP, Tsong Y, Sathe P, et al. In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharm Res. 1998;15:889–896.
   PubMed Web of Science ®Google Scholar
• Yuksel N, Kanik AE, Baykara T. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int J Pharm. 2000;209:57–67.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). Guidance for industry: immediate release solid oral dosage forms; Scale-up and postapproval changes: chemistry, manufacturing, and controls; In vitro dissolution testing; In vivo bioequivalence documentation. Rockville (MD): Center for Drug Evaluation and Research; 1995.
   Google Scholar
• Food and Drug Administration (FDA). Guidance for industry: dissolution testing of immediate release solid oral dosage forms. Rockville, MD: Center for Drug Evaluation and Research;1997.
   Google Scholar
• Food and Drug Administration (FDA). 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 bioequivalance documentation. Rockville (MD): Center for Drug Evaluation and Research;1997.
   Google Scholar
• Chow SC, Ki FYC. Statistical comparison between dissolution profiles of drug product. J Biopharm Stat. 1997;7:241–258.
   PubMedGoogle Scholar
• Liu JP, Ma MC, Chow SC. Statistical evaluation of similarity factor f2 as a criterion for assessment of similarity between dissolution profiles. Drug Information J. 1997;31:1255–1271.
   Google Scholar
• Lourenço FR, Ghisleni DDM, Yamamoto RN, et al. Comparison of dissolution profile of extended-release oral dosage forms – two one-sided equivalence test. Braz J Pharm Sci. 2013;49:367–371.
   Web of Science ®Google Scholar
• Ma MC, Lin RP, Liu JP. Statistical evaluations of dissolution similarity. Stat Sin. 1999;9:1011–1027.
   Web of Science ®Google Scholar
• Saranadasa H, Krishnamoorthy K. A multivariate test for similarity of two dissolution profiles. J Biopharm Stat. 2005;15:265–278.
   PubMed Web of Science ®Google Scholar
• Wang Y, Snee RD, Keyvan G, et al. Statistical comparison of dissolution profiles. Drug Dev Ind Pharm. 2016; 42:796–807.
   PubMed Web of Science ®Google Scholar
• Chow SC, Shao J. Statistics in drug research: methodologies and recent developments. New York (NY): Chapman & Hall/CRC; 2002.
   Google Scholar
• Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. 3rd ed. New York (NY): Chapman & Hall/CRC; 2008.
   Google Scholar
• Gómez Mantilla JD. Statistical Approaches to Perform Dissolution Profile Comparisons. Unpublished PhD thesis. Saarland University, Saarbrücken, Germany; 2013.
   Google Scholar
• Zhai S. Tolerance Limits and Hypotheses Tests for the Comparison of Dissolution Profiles. Unpublished PhD thesis, University of Maryland Baltimore County, MD, USA; 2015.
   Google Scholar
• Bogdanoff JL, Kozin F. Probabilistic models of cumulative damage. New York (NY): John Wiley & Sons; 1985.
   Google Scholar
• Zhou RR, Serban N, Gebraeel N. Degradation modeling applied to residual lifetime prediction using functional data analysis. Ann Appl Stat. 2011;5:1586–1610.
   Web of Science ®Google Scholar
• Gorjian N, Ma L, Mittinty M, et al. A review on degradation models in reliability analysis. In: Kiritsis D, Emmanouilidis C, Koronios A, Mathew J, editors. Engineering asset lifecycle management: Proceedings of the 4th World Congress on Engineering Asset Management. London (UK): Springer; 2009. p. 369–384.
   Google Scholar
• Lu CJ, Meeker WQ. Using degradation measures to estimate a time-to-failure distribution. Technometrics. 1993;35:161–174.
   Web of Science ®Google Scholar
• Meeker WQ, Escobar LA, Lu CJ. Accelerated degradation tests: modeling and analysis. Technometrics. 1998;40:89–99.
   Web of Science ®Google Scholar
• Tang LC, Chang DS. Reliability prediction using nondestructive accelerated-degradation data: case study on power supplies. IEEE Trans Reliab. 1995;44:562–566.
   Web of Science ®Google Scholar
• Çinlar E. On a generalization of gamma processes. J Appl Probab. 1980;17:467–480.
   Web of Science ®Google Scholar
• Pandey MD, van Noortwijk JM. Gamma process model for time-dependent structural reliability analysis. In: Watanabe E, Frangopol DM, Utsonomiya T, editors. Bridge maintenance, safety, management and cost. Proceedings of the second international conference on bridge maintenance, safety and management (IABMAS), Kyoto, Japan, 18–22 October 2004. London: Taylor and Francis Group.
   Google Scholar
• van Noortwijk JM. A survey of the application of gamma processes in maintenance. Reliab Eng Syst Saf. 2009; 94:2–21.
   Web of Science ®Google Scholar
• Berger RL, Hsu JC. Bioequivalence trials, intersection union tests and equivalence confidence sets. Stat Sci. 1996;11:283–319.
   Web of Science ®Google Scholar
• Halperin M. Almost linearly-optimum combination of unbiased estimates. J Am Stat Assoc. 1961;56:36–43.
   Web of Science ®Google Scholar
• Ocaña J, Frutos G, Sánchez P. Using the similarity factor f2 in practice: a critical revision and suggestions for its standard error estimation. Chemometr Intell Lab Syst. 2009;99:49–56.
   Web of Science ®Google Scholar
• Tsong Y, Hammerstrom T, Sathe P, et al. Statistical assessment of mean differences between two dissolution data sets. Drug Information J. 1996;30:1105–1112.
   Google Scholar