Tests for inter-subject and total variabilities under crossover designs

Journal of Biopharmaceutical Statistics

Volumn 12, Issue 4, 2002, Pages 503-534

  Lee, Yonghee ^a,b   Shao, Jun ^a   Chow, Shein Chung ^b   Wang, Hansheng ^b  

^a UNIVERSITY OF WISCONSIN MADISON   (United States)

^b StatPlus Inc   (United States)

Author keywords

Modified large sample; Power; Replicated crossover design; Sample size calculation; Sensitivity analysis

Indexed keywords

ARTICLE; CALCULATION; CLINICAL RESEARCH; CROSSOVER PROCEDURE; HUMAN; MONTE CARLO METHOD; PRIORITY JOURNAL; PROBABILITY; SAMPLE SIZE; SAMPLING; STATISTICAL ANALYSIS; ANALYSIS OF VARIANCE; BIOASSAY; CLINICAL TRIAL; COMPUTER SIMULATION; METHODOLOGY; STATISTICAL MODEL; STATISTICS;

ANALYSIS OF VARIANCE; CLINICAL TRIALS; COMPUTER SIMULATION; CROSS-OVER STUDIES; ENDPOINT DETERMINATION; HUMANS; MODELS, STATISTICAL; MONTE CARLO METHOD; RESEARCH DESIGN; SAMPLE SIZE;

EID: 0036448950     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120016233     Document Type: Article

References (10)

1. FDA. In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches; Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, MD, 1999.
2. FDA. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products - General Considerations; Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, MD, 2000.
3. FDA. Statistical Approaches to Establishing Bioequivalence; Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, MD, 2001.
4. Chinchilli, V.M.; Esinhart, J.D. Design and analysis of intra-subject variability in cross-over design. Stat. Med. 1996, 15, 1619-1634.
5. Graybill, F.A.; Wang, C.-M. Confidence intervals on nonnegative linear combinations of variances. J. Am. Stat. Assoc. 1980, 75, 869-873.
6. Ting, N.; Burdick, R.K.; Graybill, F.A.; Jeyaratnam, S.; Lu, T.-F.C. Confidence intervals on linear combinations of variance components that are unrestricted in sign. J. Stat. Comput. Simulat. 1990, 35, 135-143.
7. Hyslop, T.; Hsuan, F.; Holder, D.J. A small sample confidence interval approach to assess individual bioequivalence. Stat. Med. 2000, 19, 2885-2897.
8. Wang, W. On equivalence of two variances of a bivariate normal vector. J. Stat. Plann. Inference 1999, 81, 279-292.
9. Lee, Y. Confidence Intervals and Tests on a Linear Combination of Variance Components When Estimators Are Dependent. Ph.D. Thesis, University of Wisonsin at Madison, 2002.
10. Lee, Y.; Shao, J.; Chow, S.-C. Confidence Interval for Linear Combinations of Variance Components When Estimators of Variance Components Are Dependent: An Extension of Modified Large Sample Method with Applications. 2002, submitted for publication.