Statistical evaluation of individual bioequivalence

Communications in Statistics - Theory and Methods

Volumn 27, Issue 6, 1998, Pages 1433-1451

  Liu, Jen Pei ^a  

^a NATIONAL CHENG KUNG UNIVERSITY   (Taiwan)

Author keywords

Average; Individual bioequivalence; Intrasubject variability; Subject by formulation interaction; Switchability

Indexed keywords

EID: 0005362710     PISSN: 03610926     EISSN: None     Source Type: Journal    
DOI: 10.1080/03610929808832168     Document Type: Review

References (21)

1. Albert, K.S. and Smith, R.G. (1980) 'Bioavailability assessment as influenced by variation in drug absorption' in Albert, K.S. edited "Drug Absorption Disposition: Statistical Considerations" American Pharmaceutical Association, Washington, D.C., pp. 87-113.
2. Anderson, S. (1993) Individual bioequivalence: a problem of switchability (with discussion), Biopharmaceutical Report, 2, 1-11.
3. Berger, R. L. (1982) Multiparametric hypothesis testing and acceptance sampling, Technometrics, Vol. 24, 295-300.
4. Chen, M.L. (1996) Individual bioequivalence criterion, presented at the meeting of the Advisory Committee for Pharmaceutical Science on August 15-16, 1996, Gaithersburg, M.D., U.S.A.
5. Chen, M.L. (1997) Individual bioequivalence - a regulatory update. Journal of Biopharmaceutical Statistics, 7, 5-11.
6. Chinchilli, V.M. (1996) The assessment of individual and population bioequivalence, Journal of Biopharmaceutical Statistics, 6, 1-14.
7. Chinchilli, V.M. and Esinhart, J.D. (1994) Extension to the use of tolerance interval for the assessment of individual bioequivalence. Journal of Biopharmaceutical Statistics, 4, 39-52.
8. Chow, S.C., and Liu, J.P. (1992) Design and Analysis of Bioavailability and Bioequivalence, Marcel Dekker, Inc., New York, New York, U.S.A.
9. Chow, S.C., and Liu, J.P (1995) Current issues in bioequivalence trials, Drug Information Journal, 29, 795-804.
10. Hauck, W.W., (1996) Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence, Intl. J. Clin. Pharmacol. Ther. Toxicol., 34, 535-541.
11. Hauck, W.W., and Anderson, S. (1992) Types of bioequivalence and related statistical considerations, Intl. J. Clin. Pharmacol. Ther. Toxicol. 30, 181-187.
12. Johnson, N.L., and Kotz, S. (1970) Distributions in Statistics: Continuous Univariate Distributions-2, John Wiley and sons, New York, New York, U.S.A.
13. Liu, J.P. (1995) Use of the repeated cross-over designs in assessing bioequivalence, Statistics in Medicine, 14, 1067-1078.
14. Liu, J.P. , and Chow, S.C. (1995) Replicated crossover design in bioavailabilhy and bioequivalence trials, Drug Information Journal, Vol. 29, 871-884.
15. Liu, J.P., and Chow, S.C (1996) Discussion of "Bioequivalence trials, intersection-union tests and equivalence confidence sets" by Berger and Hsu, Statistical Sciences, 11, 306-312.
16. Liu, J.P., and Chow, S.C (1997) Some thoughts on individual bioequivalence, Journal of Biopharmaceutical Statistics, Vol. 7(1), 41-48.
17. Schall R. (1995) Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar, Biometrics, Vol 51, 615-626.
18. Schall, R., and Luus, H.G. (1993) On population and individual bioequivalence, Statistics in Medicine, 12, 1109-1124.
19. Sheiner, L.B. (1992) Bioequivalence revisited, Statistics in Medicine, Vol. 11, 1777-1788.
20. Vuorinen, J. (1997) A practical approach for the assessment of bioequivalence under selected higher-order cross-over designs, Statistics in Medicine, 16, 2229-2243.
21. Vuorinen, J. and Turunen, J. (1996) A three-step procedure for assessing bioequivalence in the general mixed model framework, Statistics in Medicine, 15, 2635-2655.