References
- Anderson S., Hauck W. W. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Communication of Statistical Theory and Methodology 1983; 12: 2663–2692
- Anderson S., Hauck W. Consideration of individual bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 1990; 18: 259–273
- FDA Document. Report by the bioequivalence task force on recommendations from the bioequivalence hearing conducted by the FDA. 1988
- 1977; 39675–39672, Federal Register 42
- 1978; 5965–6969, Federal Register 43
- 1980; 11849–11854, Federal Register 45
- Fluehler H., Hirtz J., Moser H. A. An aid to decision making in bioequivalence assessment. Journal of Pharmacokinetics and Biopharmaceutics 1981; 235–243
- Grizzle J. E. The two-period change-over design and its use in clinical trials. Biometrics 1965; 21: 467–480
- Hauck W. W., Anderson S. A new statistical procedure for testing equivalence in two group comparative bioavailability trials. Journal of Pharmacokinetics and Biopharmaceutics 1984; 12: 83–91
- Haynes J. D. Statistical simulation study of new proposed uniformity requirement for bioequivalency studies. Journal of Pharmaceutical Sciences 1981; 70: 673–675
- Kirkwood T. B. L. Bioequivalence testing—a need to rethink. Biometrics 1981; 37: 589–591
- Koch G. G. The use of non-parametric methods in the statistical analysis of the two-period change over design. Biometrics 1972; 28: 577–584
- Mandallaz D., Mau J. Comparison of different methods for decision making in bioequivalence assessment. Biometrics 1981; 37: 213–222
- Mantel N. Do we want confidence intervals symmetrical about the null value?. Biometrics 1977; 33: 759–760
- Pabst G., Jaeger H. Review of methods and criteria for the evaluation of bioequivalence studies. European Journal of Clinical Pharmacology 1990; 38: 5–10
- Pearson E. S., Hartley H. O. Biometrika Tables for Statisticians. Biometrika Trust, London 1976
- Rodda B. E., Davis R. L. Determining the probability of an important difference in bioavailability. Clinical Pharmacology and Therapeutics 1980; 28: 247–252
- Schuirmann D. J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of Pharmacokinetics and Biopharmaceutics 1987; 15: 657–680
- Selwyn M. R., Hall N. R. On Bayesian methods for bioequivalence. Biometrics 1984; 40: 1103–1108
- Shapiro S. S., Wilk M. B. An analysis of variance test for normality (complete samples). Biometrika 1965; 52: 591–611
- Spriet A., Beiler D. Table to facilitate determination of symmetrical intervals in bioavailability trials with Westlake's method. European Journal of Drug Metabolism and Pharmacokinetics 1978; 2: 129–132
- Steinijans V. W., Diletti E. Statistical analysis of bioavailability studies: parametric and non-parametric confidence intervals. European Journal of Clinical Pharmacology 1983; 24: 127–136
- Steinijans V. W., Diletti E. Generalisation of distribution-free confidence intervals for bioavailability ratios. European Journal of Clinical Pharmacology 1985; 28: 85–88
- Urso R., Aarons L. Bioavailability of drugs with long elimination half-lives. European Journal of Clinical Pharmacology 1983; 25: 689–693
- Wallenstein S., Fisher A. C. The analysis of the two-period repeated measurements crossover design with application to clinical trials. Biometrics 1977; 33: 261–269
- Westlake W. J. Use of statistical methods in evaluation of in-vivo performance of dosage forms. Journal of Pharmaceutical Sciences 1973a; 62: 1579–1589
- Westlake W. J. The design and analysis of comparative blood-level trials. Dosage Form Design and Bioavailability, J. Swarbrick. Lea & Febiger, Philadelphia 1973b; 149–179
- Westlake W. J. Symmetrical confidence intervals for bioequivalence. Biometrics 1976; 32: 741–744
- Westlake W. J. Statistical aspects of bioavailability trials. Biometrics 1979; 35: 273–280
- Westlake W. J. Design and statistical evaluation of bioequivalence studies in man. Principles and Perspectives in Drug Bioavailability, J. Blanchard, R. S. Sawchuk, B. B. Brodie. Karger, Basel 1980; 192–210
- Westlake W. J. Bioavailability and bioequivalence of pharmaceutical formulations. Biopharmaceutical Statistics for Drug Development, K. E. Peace. Marcel Dekker, New York 1988; 329–352
- Winer B. J. Statistical Principles in Experimental Design. McGraw-Hill, New York 1971; 205–210