Основная литература

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2. Фирсов А.А., Пиотровский В.К. Фармакокинетические методы в биоинформации. Итоги науки и техники. - М.: ВИНИТИ, 1984. Т.14.- С.114 - 227.
3. Bioequivalence Assessment. Methods and Applications, Ed. Steinijans V. W. Int. J. Clin. Pharmacol. Ther. and Toxicol., Vol. 30 (Suppl. 1), 1992, pp. 1-66.
4. Investigation of Bioavailability and Bioequivalence - Commission of the European Communities, III/54/89-EN, December 1991, pp. 1-20.
5. In vivo bioequivalence guidances - U.S. Pharmacopeia 24-NF 19, Supplement 2, 2000, 1090, pp. 2056-2098.
6. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. - The European Agency for the Evaluation of Medical Products, Committee for Proprietary Medicinal Products, London, July 2001, pp. 1-18.
7. Statistical Approaches to Establishing Bioequivalence. - U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, January 2001.
8. Waiver of in vivo Bioavailability and Bioequivalence Studies for Immediate - Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. - U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research, August 2000.
9. Diletti E., Hauschke D., Steinijans V. W. Int. J. Clin. Pharmacol. Ther. and Toxicol. Sample size determination for bioequivalence assessment by means of confidence intervals. 1991, Vol. 29, pp. 1-8.
10. Hauschke D., Steinijans V. W., Diletti E. A. Distribution-free Procedure for the Statistical Analysis of Bioequivalence Studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 1990, Vol. 28, pp. 72-78.
11. Hills M., Armitage P. The Two-Period Cross-Over Clinical Trial. Br. J. Clin. Pharmac. 1979, Vol. 8, pp. 7-20.
12. Lund R. E. Tables for an Approximate Test for Outliers in Linear Models. Technometrics. 1975, Vol. 17, pp 473-476.
13. Schuirmann D. J. A comparison of the two one-side tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 1987, Vol. 15, pp. 657-680.
14. Shein-Shung Chow, Jen-Pei Liu. Design and Analysis of Bioavailability and Bioequivalent Studies. Marcel Dekker, New York, 1992.
15. Steinijans V. W., Diletti E. Statistical Analysis of Bioavailability Studies: Parametric and Nonparametric Confidence Intervals. Eur. J. Clin. Pharmacol. 1983, Vol. 24, pp 127-136.
16. Steinijans V. W., Sauter R., Jonkman H. G., et al. Bioequivalence Studies: Single vs Multiple Dose. Int. J. Clin. Pharmacol. Ther. Toxicol. 1989, Vol. 27, pp. 261-266.
17. Wijnand H. P. Bioequivalence assessment of drug formulations. Non-parametric versus parametric analysis. Doctor's thesis. Leiden, 1994, pp. 1 - 60.