A survey of the likelihood approach to bioequivalence trials

Statistics in Medicine

Volumn 27, Issue 24, 2008, Pages 4874-4894

  Choi, Leena ^a   Caffo, Brian ^b   Rohde, Charles ^b  

^a VANDERBILT UNIVERSITY   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Likelihood principle; Misleading evidence; Population bioequivalence; Profile likelihood

Indexed keywords

DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CONFIDENCE INTERVAL; CONFOUNDING VARIABLE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG ELIMINATION; HYPOTHESIS; INTERMETHOD COMPARISON; MAXIMUM PLASMA CONCENTRATION; PROBABILITY; SIMULATION; STATISTICAL MODEL; TIME TO MAXIMUM PLASMA CONCENTRATION; CLINICAL TRIAL; PHARMACOKINETICS; STATISTICS;

AREA UNDER CURVE; CLINICAL TRIALS AS TOPIC; LIKELIHOOD FUNCTIONS; MODELS, STATISTICAL; THERAPEUTIC EQUIVALENCY;

EID: 59849128647     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3334     Document Type: Article

References (36)

1. Schulz HU, Steinijans VW. Striving for standards in bioequivalence assessment: a review. International Journal of Clinical Pharmacology, Therapy and Toxicology 1991; 29(8):293-298.
2. Metzler CM. Bioavailability - a problem in equivalence. Biometrics 1974; 30:309-317.
3. Blume JD. Likelihood methods for measuring statistical evidence. Statistics in Medicine 2002; 21:2563-2599.
4. max for absorption rates in investigations of bioequivalence. International Journal of Clinical Pharmacology, Therapy, and Toxicology 1991; 29:394-399.
5. Chen ML. An alternative approach for assessment of rate of absorption in bioequivalence studies. Pharmaceutical Research 1992; 9:1380-1385.
6. Bois FY, Tozer TN, Hauck WW, Chen ML, Patnaik R, Williams RL. Bioequivalence: performance of several measures of rate of absorption. Pharmaceutical Research 1994; 11:966-974.
7. Limpert E, Stahel W, Abbt M. Log-normal distributions across the sciences: keys and clues. BioScience 2001; 51:341-352.
8. Kenney JF, Keeping ES. Mathematics of Statistics. D. Van Nostrand: New York, 1951.
9. Midha KK, Ormsby ED, Hubbard JW, McKay G, Hawes EM, Gavalas L. Logarithmic transformation in bioequivalence: application with two formulations of Perphenazine. Journal of Pharmaceutical Sciences 1993; 82:138-144.
10. FDA guidance. Statistical Approaches to Establishing Bioequivalence. U.S. Food and Drug Administration, U.S.A., 2001.
11. Westlake WJ. Bioavailability and bioequivalence of pharmaceutical formulations. Biopharmaceutical Statistics for Drug. Marcel Dekker: New York, 1987; 329-352.
12. Friedman H, Greenblatt DJ, Burstein ES, Harmatz JS, Shader RI. Population study of triazolam pharmacokinetics. British Journal of Clinical Pharmacology 1986; 22:639-642.
13. Lacey LF, Keene ON, Pritchard JF, Bye A. Common noncompartmental pharmacokinetic variables: are they normally or log-normally distributed? Journal of Biopharmaceutical Statistics 1997; 7:171-178.
14. Mizuta E, Tsubotani A. Preparation of mean drug concentration-time curves in plasma: a study on the frequency distribution of pharmacokinetic parameters. Chemical Pharmaceutical Bulletin 1985; 33:1620-1632.
15. Jones B, Kenward MG. Design and Analysis of Cross-over Trials (2nd edn). Chapman & Hall/CRC Press: London/Boca Raton, 2003.
16. Zariffa NMD, Patterson SD, Boyle D, Hyneck M. Case studies, practical issues and observations on population and individual bioequivalence. Statistics in Medicine 2000; 19:2811-2820.
17. D'Angelo G, Potvin D, Turgeon J. Carry-over effects in bioequivalence studies. Journal of Biopharmaceutical Statistics 2001; 11:35-43.
18. Anderson S, Hauck WW. Consideration of individual bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 1990; 18:259-273.
19. Liu J-P, Chow S-C. Comment on Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statistical Science 1996; 11:306-312.
20. Hwang JTG. Comment on Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statistical Science 1996; 11:313-315.
21. Kirkwood TBL. Bioequivalence testing: a need to rethink (reader reaction). Biometrics 1981; 37:589-591.
22. Westlake WJ. Symmetric confidence intervals for bioequivalence trials. Biometrics 1976; 32:741-744.
23. Anderson S, Hauck WW. A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Communications in Statistics - Theory and Methods 1983; 12:2663-2692.
24. Locke CS. An exact confidence interval for untransformed data for the ratio of two formulation means. Journal of Pharmacokinetics and Biopharmaceutics 1984; 12:649-655.
25. Schuirmann DJ. 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.
26. Berger RL, Hsu JC. Bioequivalence trials, intersection-union tests and equivalence confidence sets (Disc: P303-319). Statistical Science 1996; 11:283-302.
27. Blume J, Peipert JF. What your statistician never told you about P-values. Journal of the American Association of Gynecologic Laparoscopists 2003; 10:439-444.
28. Hacking I. Logic of Statistical Inference. Cambridge University Press: New York, 1965.
29. Edwards AWF. Likelihood. Cambridge University Press: London, 1972.
30. Royall RM. Statistical Evidence: A Likelihood Paradiam. Chapman & Hall/CRC: London/Boca Raton, 1997.
31. Birnbaum A. On the foundations of statistical inference (Com: P307-326). Journal of the American Statistical Association 1962; 57:269-306.
32. Royall RM. On the probability of observing misleading statistical evidence (C/R: P768-780). Journal of the American Statistical Association 2000; 95:760-768.
33. Pawitan Y. In All Likelihood: Statistical Modelling and Inference Using Likelihood. Oxford University Press: Oxford, 2001.
34. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies (2nd edn). Marcel Dekker: New York, 2000.
35. Blume JD. How to choose a working model for measuring the statistical evidence about a regression parameter. International Statistical Review 2005; 73:351-363.
36. Cox DR. Some problems connected with statistical inference. Annals of Mathematical Statistics 1958; 29:357-372.