[1] |
Yu LX, Li BV. FDA bioequivalence standards. New York: AAPS Press/Springer, 2014. |
[2] |
Chow SC, Liu JP. Design and analysis of bioavailability and bioequivalence studies. Boca Raton: CRC Press, 2009. |
[3] |
Endrenyi L, Blume HH, Tothfalusi L. The Two Main Goals of Bioequivalence Studies. AAPS J, 2017; 19, 885-90. doi: 10.1208/s12248-017-0048-x |
[4] |
Harigaya Y, Jiang X, Zhang H, et al. Bioequivalence Study Methods with Pharmacokinetic Endpoints for Topical Ophthalmic Corticosteroid Suspensions and Effects of Subject Demographics. Pharmaceutical Res, 2018; 36, 13. doi: 10.1007/s11095-018-2537-8 |
[5] |
Zhu H, Chauhan A. Effect of viscosity on tear drainage and ocular residence time. Optom Vis Sci, 2008; 85, 715-25. doi: 10.1097/OPX.0b013e3181824dc4 |
[6] |
Li M, Wang ZL, Gou LY, et al. Evaluation of the protein requirement in Chinese young adults using the indicator amino acid oxidation technique. Biomed Environ Sci, 2013; 26, 655-62. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=bes201308004 |
[7] |
Ahmed I, Patton TF. Importance of the noncorneal absorption route in topical ophthalmic drug delivery. Invest Ophthalmol Vis Sci, 1985; 26, 584-7. http://www.ncbi.nlm.nih.gov/pubmed/3884542 |
[8] |
Zhang YP, Peng XY, Li ZH, et al. Hyperglycemic effects of a periocular dexamethasone injection in diabetic patients after vitreoretinal surgery. Biomed Environ Sci, 2012; 25, 311-6. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=bes201203009 |
[9] |
Deng F, Ranta VP, Kidron H, et al. General Pharmacokinetic Model for Topically Administered Ocular Drug Dosage Forms. Pharmaceutical Research, 2016; 33, 2680-90. doi: 10.1007/s11095-016-1993-2 |
[10] |
Wolfsegger MJ. Establishing bioequivalence in serial sacrifice designs. J Pharmacokinet Pharmacodyn, 2007; 34, 103-13. doi: 10.1007/s10928-006-9037-x |
[11] |
Jaki T, Wolfsegger MJ, Lawo JP. Establishing Bioequivalence in Complete and Incomplete Data Designs Using AUCs. J Biopharm Stat, 2010; 20, 803-20. doi: 10.1080/10543401003618835 |
[12] |
Wolfsegger MJ, Jaki T. Assessing Systemic Drug Exposure in Repeated Dose Toxicity Studies in the Case of Complete and Incomplete Sampling. Biom J, 2009; 51, 1017-29. http://med.wanfangdata.com.cn/Paper/Detail/PeriodicalPaper_PM19998360 |
[13] |
Jaki T, Wolfsegger MJ, Ploner M. Confidence intervals for ratios of AUCs in the case of serial sampling:a comparison of seven methods. Pharm Stat, 2009; 8, 12-24. doi: 10.1002/pst.321 |
[14] |
Hua SY, Hawkins DL, Zhou J. Statistical considerations in bioequivalence of two area under the concentration-time curves obtained from serial sampling data AU-Hua, Steven Y. J Applied Stat, 2013; 40, 1140-54. doi: 10.1080/02664763.2013.780234 |
[15] |
Shen MY, Machado SG. Bioequivalence evaluation of sparse sampling pharmacokinetics data using bootstrap resampling method. J Biopharm Stat, 2017; 27, 257-64. doi: 10.1080/10543406.2016.1265543 |
[16] |
Jaki T, Pallmann P, Wolfsegger MJ. Estimation in AB/BA crossover trials with application to bioequivalence studies with incomplete and complete data designs. Stat Med, 2013; 32, 5469-83. doi: 10.1002/sim.5886 |
[17] |
Locke CS. An exact confidence interval from untransformed data for the ratio of two formulation means. J Pharmacokinet Biopharm, 1984; 12, 649-55. doi: 10.1007/BF01059558 |
[18] |
Herson J. Fieller's theorem vs. The delta method for significance intervals for ratios. J Stat Computation Simulation, 1975; 3, 265-74. doi: 10.1080/00949657508810091 |
[19] |
Bailer AJ. Testing for the equality of area under the curves when using destructive measurement techniques. J Pharmacokine Biopharm, 1988; 16, 303-9. doi: 10.1007/BF01062139 |
[20] |
Jones B, Kenward MG. Design and analysis of cross-over trials. Boca Raton: CRC Press/Taylor & Francis, 2014. |
[21] |
Satterthwaite FE. An Approximate Distribution of Estimates of Variance Components. Biometrics Bulletin, 1946; 2, 110-4. doi: 10.2307/3002019 |
[22] |
Fieller EC. Some Problems in Interval Estimation. Journal of the Royal Statistical Society Series B (Methodological), 1954; 16, 175-85. doi: 10.1111/j.2517-6161.1954.tb00159.x |
[23] |
Hauschke D, Kieser M, Diletti E, et al. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stat Med, 1999; 18, 93-105. doi: 10.1002/(SICI)1097-0258(19990115)18:1<93::AID-SIM992>3.0.CO;2-8 |
[24] |
Berger RL, Hsu JC. Bioequivalence Trials, Intersection-Union Tests and Equivalence Confidence Sets. Stat Sci, 1996; 11, 283-302. doi: 10.1214/ss/1032280304 |
[25] |
Sasabuchi S. A Test of a Multivariate Normal Mean with Composite Hypotheses Determined by Linear Inequalities. Biometrika, 1980; 67, 429-39. doi: 10.1093/biomet/67.2.429 |
[26] |
Hirschberg J, Lye J. A Geometric Comparison of the Delta and Fieller Confidence Intervals. Am Stat, 2010; 64, 234-41. doi: 10.1198/tast.2010.08130 |
[27] |
Julious SA. Sample sizes for clinical trials with Normal data. Stat Med, 2004; 23, 1921-86. doi: 10.1002/sim.1783 |
[28] |
Chiambaretta F, Garraffo R, Elena PP, et al. Tear concentrations of azithromycin following topical administration of a single dose of azithromycin 0.5%, 1.0%, and 1.5% eyedrops (T1225) in healthy volunteers. Eur J Ophthalmol, 2008; 18, 13-20. doi: 10.1177/112067210801800103 |
[29] |
Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising:A practical guide with examples. Stat Med, 2011; 30, 3267-84. doi: 10.1002/sim.4102 |
[30] |
Maurer W, Jones B, Chen Y. Controlling the type Ⅰ error rate in two-stage sequential adaptive designs when testing for average bioequivalence. Stat Med, 2018; 37, 1587-607. doi: 10.1002/sim.7614 |
[31] |
Potvin D, DiLiberti CE, Hauck WW, et al. Sequential design approaches for bioequivalence studies with crossover designs. Pharmaceutical Stat, 2008; 7, 245-62. doi: 10.1002/pst.294 |
[32] |
Kieser M, Rauch G. Two-stage designs for cross-over bioequivalence trials. Stat Med, 2015; 34, 2403-16. doi: 10.1002/sim.6487 |
[33] |
Xu J, Audet C, DiLiberti CE, et al. Optimal adaptive sequential designs for crossover bioequivalence studies. Pharmaceutical Stat, 2016; 15, 15-27. doi: 10.1002/pst.1721 |
[34] |
Yan F, Zhu H, Liu J, et al. Design and inference for 3-stage bioequivalence testing with serial sampling data. Pharmaceutical Stat, 2018; 17, 458-76. http://europepmc.org/abstract/MED/29726096 |