Test for individual and popution bioequivalence based on generalized p-values

Statistics in Medicine

Volumn 22, Issue 1, 2003, Pages 31-53

  McNally, Richard J ^a   Iyer, Hari ^a   Mathew, Thomas ^b  

^a Department of Environmental and Radiological Health Sciences   (United States)

^b UNIVERSITY OF MARYLAND   (United States)

Author keywords

Bioequivalence; Crossover designs; Generalized p value; Linear mixed model; Variance components

Indexed keywords

METHYLPHENIDATE; VERAPAMIL; ADRENERGIC RECEPTOR STIMULATING AGENT; CALCIUM CHANNEL BLOCKING AGENT; DRUG;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BIOSTATISTICS; CONFIDENCE INTERVAL; CONTROLLED STUDY; DRUG APPROVAL; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN EXPERIMENT; HYPOTHESIS; INTERMETHOD COMPARISON; MALE; MEDICAL LITERATURE; METHODOLOGY; MONTE CARLO METHOD; NORMAL HUMAN; PRESCRIPTION; SAMPLE SIZE; STATISTICAL MODEL; BIOLOGICAL MODEL; COMPARATIVE STUDY; COMPUTER SIMULATION; DRUG LEGISLATION; PHARMACOKINETICS; STANDARD; STATISTICAL ANALYSIS; UNITED STATES;

ADRENERGIC AGENTS; AREA UNDER CURVE; CALCIUM CHANNEL BLOCKERS; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; HUMANS; LEGISLATION, DRUG; MALE; METHYLPHENIDATE; MODELS, BIOLOGICAL; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VERAPAMIL;

EID: 0037437299     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1346     Document Type: Article

References (24)

1. Anderson S, Hauck WW. Consideration of individual bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 1990; 18:259-273.
2. Hauck WW, Anderson S. Individual bioequivalence: what matters to the patient. Statistics in Medicine 1991; 10:959-959.
3. Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker: New York, 2000.
4. Schall R, Luus HG. On population and individual bioequivalence. Statistics in Medicine 1993; 12:1109-1124.
5. Schall R. Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics 1995; 51:615-626.
6. Sheiner LB. Bioequivalence revisited. Statistics in Medicine 1992; 11:1777-1788.
7. US Food and Drug Administration. Statistical approaches to establishing bioequivalence. Rockville, MD, 2001.
8. Holder DJ, Hsuan F. Moment-based criteria for determining bioequivalence. Biometrika 1993; 80:835-846.
9. Ekbohm G, Melander H. The subject-by-formulation interaction as a criterion for interchangeability of drugs. Biometrics 1989; 45:1249-1254.
10. Hsuan F. Some statistical considerations on the FDA draft guidance for individual bioequivalence. Statistics in Medicine 2000; 19:2879-2884.
11. Hyslop T, Hsuan F, Holder DJ. A small sample confidence interval approach to assess individual bioequivalence. Statistics in Medicine 2000; 19:2885-2897.
12. Howe WG. Approximate confidence limits on the mean of X + Y where X and Y are two tabled independent random variables. Journal of the American Statistical Association 1974; 69:789-794.
13. Quiroz J, Ting N, Wei GCG, Burdick RK. Alternative confidence intervals for the assessment of bioequivalence in four-period cross-over designs. Statistics in Medicine 2002; 21:1825-1847.
14. Graybill FA, Wang CM. Confidence intervals on nonnegative linear combinations of variances. Journal of the American Statistical Association 1980; 75:869-873.
15. Burdick RK, Graybill FA. Confidence Intervals on Variance Components. Marcel Dekker: New York, 1992.
16. Tsui KW, Weerahandi S. Generalized p-values in significance testing of hypotheses in the presence of nuisance parameters. Journal of the American Statistical Association 1989; 84:602-607.
17. Weerahandi S. Testing variance components in mixed models with generalized p values. Journal of the American Statistical Association 1991; 86:151-153.
18. Weerahandi S. Generalized confidence intervals. Journal of the American Statistical Association 1993; 88: 899-905.
19. Zhou L, Mathew T. Some tests for variance components using generalized p values. Technometrics 1994; 36:394-402.
20. Weerahandi S. Exact Statistical Methods in Data Analysis. Springer-Verlag: New York, 1995.
21. Chinchilli VM, Esinhart JD. Design and analysis of intra-subject variability in cross-over experiments. Statistics in Medicine 1996; 15:1619-1634.
22. Meyer MC, Straughn AB, Jarvi EJ, Patrick KS, Pelsor FR, Williams RL, Patnaik R, Chen ML, Shah VP. Bioequivalence of methylphenidate immediate-release tablets using a replicated study design to characterize intrasubject variability. Pharmaceutical Research 2000; 17:381-384.
23. Efton B, Tibshirani RJ. An Introduction to the Bootstrap. Chapman & Hall: New York, 1993.
24. Shumaker RC, Metzler CM. The phenytoin trial is a case study of 'individual' bioequivalence. Drug Information Journal 1998; 32:1063-1072.