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Research Article

In vitro dissolution profile comparison using bootstrap bias corrected similarity factor, f2

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Pages 78-89 | Received 01 Apr 2021, Accepted 17 Jan 2023, Published online: 29 Jan 2023

References

  • Amidon, G. L., H. Lennernäs, V. P. Shah, and J. R. Crison. 1995. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research 12 (3):413–420. doi:10.1023/A:1016212804288.
  • Anand, O. M., X. Yu Lawrence, D. P. Conner, and B. M. Davit. 2011. Dissolution testing for generic drugs: An FDA perspective. The AAPS Journal 13 (3):328. doi:10.1208/s12248-011-9272-y.
  • Costa, P., and J. Manuel Sousa Lobo. 2001. Modeling and comparison of dissolution profiles. European Journal of Pharmaceutical Sciences 13 (2):123–133. doi:10.1016/S0928-0987(01)00095-1.
  • Duan, J. Z., K. Riviere, and P. Marroum. 2011. In vivo bioequivalence and in vitro similarity factor (f2) for dissolution profile comparisons of extended release formulations: How and when do they match? Pharmaceutical Research 28 (5):1144–1156. doi:10.1007/s11095-011-0377-x.
  • Efron, B., and R. J. Tibshirani. 1994. An introduction to the bootstrap. New York: Chapman & Hall 1993.
  • Gillespie, W. R. 1997a. Convolution-based approaches for in vivo-in vitro correlation modeling. In Vitro-in Vivo Correlations, ed.D. Young, J. G. Devane, and J. Butler, 53–65. New York, NY: Springer.
  • Gillespie, W. R. 1997b. Convolution-based approaches for in vivo-in vitro correlation modeling. In Vitro-In Vivo Correlations Advances in Experimental Medicine and Biology 423: IX, 300.
  • Hoffelder, T., R. Gössl, and S. Wellek. 2015. Multivariate equivalence tests for use in pharmaceutical development. Journal of Biopharmaceutical Statistics 25 (3):417–437. doi:10.1080/10543406.2014.920344.
  • Hsu, J.Y., M.Y. Hsu, C.C. Liao, and H.C. Hsu. 1998. On the characteristics of the FDA’s similarity factor for comparison of drug dissolution. Journal of Food and Drug Analysis 6 (3):553–558. doi:10.38212/2224-6614.2899.
  • Islam, M. M., and M. Begum. 2018. Bootstrap confidence intervals for dissolution similarity factor f2. Biometrics and Biostatistics International Journal 7 (5). doi:10.15406/bbij.2018.07.00237.
  • Mi-Chia, M., R.P. Lin, and J.P. Liu. 1999. Statistical evaluations of dissolution sim- ilarity. Statistica Sinica 9:1011–1027.
  • Mi-Chia, M., B. B. C. Wang, J.P. Liu, and Y. Tsong. 2000. Assessment of similarity between dissolution profiles. Journal of Biopharmaceutical Statistics 10 (2):229–249. doi:10.1081/BIP-100101024.
  • Moore, J. W., and H. H. Flanner. 1996. Mathematical comparison of dissolution profiles. Pharmaceutical Technology 20 (6):64–74.
  • Shah, V. P., and G. L. Amidon. 2014. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. The AAPS Journal 16 (5):894–898. doi:10.1208/s12248-014-9620-9.
  • Shah, V. P., Y. Tsong, P. Sathe, and J.P. Liu. 1998. In vitro dissolution pro- fi comparison—statistics and analysis of the similarity factor, f2. Pharmaceutical Research 15 (6):889–896. Pharmaceutical research. doi:10.1023/A:1011976615750.
  • Tsong, Y., T. Hammerstrom, P. Sathe, and V. P. Shah. 1996. Statistical assessment of mean diff between two dissolution data sets. Drug Information Journal 30 (4):1105–1112. doi:10.1177/009286159603000427.
  • US Food and Drug Administration Guidance. 1995a. FDA guidance for industry: Immediate release solid dosage forms: Scale-up and post approval changes (supac-ir): Chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation. In Center for Drug Evaluation and Research (CDER). US Department of Health and Human Services.
  • US Food and Drug Administration Guidance. 1995b. Supac-mr: Modifi release solid oral dosage forms scale-up and postapproval changes: Chemistry, manufacturing, and con- trols; in vitro dissolution testing and in vivo bioequivalence documentation. In Center for drug evaluation and research (CDER). US Department of Health and Human Services.
  • US Food and Drug Administration Guidance. 1997. Guidance for industry: Dissolution testing of immediate release solid oral dosage forms. In Center for drug evaluation and research (CDER). US Department of Health and Human Services.
  • Xu, Z., M. Merino-Sanjuan, V. Mangas-Sanjuan, and G.A. Alfredo. 2021. Estimators and confidence intervals of f 2 using bootstrap methodology for the comparison of dissolution profiles. Computer Methods and Programs in Biomedicine 212:106449. doi:10.1016/j.cmpb.2021.106449.
  • Zhai, S., T. Mathew, and Y. Huang. 2016. Comparison of drug dissolution profiles a proposal based on tolerance limits. Statistics in Medicine 35 (29):5464–5476. doi:10.1002/sim.7072.

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