A note on statistical methods for assessing therapeutic equivalence

Controlled Clinical Trials

Volumn 23, Issue 5, 2002, Pages 515-520

  Chow, Shein Chung ^a,b   Shao, Jun ^b  

^a StatPlus Inc   (United States)

^b University of Wisconsin Madison   (United States)

Author keywords

Confidence intervals; Significance level; Size; Two one sided tests

Indexed keywords

ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; EVALUATION; HYPOTHESIS; STATISTICAL ANALYSIS;

CLINICAL TRIALS; CONFIDENCE INTERVALS; DATA INTERPRETATION, STATISTICAL; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 0036776070     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(02)00222-2     Document Type: Article

References (10)

1. Hwang I.K., Morikawa T. Design issues in noninferiority/equivalence trials. Drug Info J. 33:1999;1205-1218.
2. Berger R.L., Hsu J.C. Bioequivalence trials, intersection-union tests and equivalence confidence sets (with discussion). Stat Sci. 11:1996;283-319.
3. Chow S.C., Liu J.P. Design and analysis of bioavailability and bioequivalence studies. 1992;Marcel Dekker, New York.
4. Blair RC, Cole SR. Two-sided equivalence testing of the difference between two means. J Appl Stat Methods. In press.
5. Westlake W.J. Symmetric confidence intervals for bioequivalence trials. Biometrics. 32:1976;741-744.
6. Liu HK. Confidence intervals in bioequivalence. Proceedings of the Biopharmaceutical Section of the American Statistical Association 1990, p. 51-54.
7. Hsu J.C. Constrained two-sided simultaneous confidence intervals for multiple comparisons with the best. Ann Stat. 12:1984;1136-1144.
8. Bofinger E. Expanded confidence intervals. Communications in Statistics, Theory and Methods. 14:1985;1849-1864.
9. Bofinger E. Expanded confidence intervals, one-sided tests and equivalence testing. J Biopharm Stat. 2:1992;181-188.
10. Brown L.D., Hwang J.T.G., Munk A. An unbiased test for the bioequivalence problem. Ann Stat. 25:1997;2345-2367.