A confidence region approach for assessing equivalence in variability of bioavailability

Biometrical Journal

Volumn 38, Issue 4, 1996, Pages 475-487

  Chen, Keh Wei ^a   Li, Gang ^a   Sun, Yanging ^a   Chow, Shein Chung ^b  

^a UNIVERSITY OF NORTH CAROLINA AT CHARLOTTE   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

Average bioavailability; Bioequivalence; Pitman Morgan two one sided tests; Variability of bioavailability

Indexed keywords

BIOCHEMISTRY; DRUG PRODUCTS;

AVERAGE BIOAVAILABILITY; BIOEQUIVALENCE; CONFIDENCE REGION; HEALTHY VOLUNTEERS; PITMAN-MORGAN TWO ONE-SIDED TEST; VARIABILITY OF BIOAVAILABILITY;

STATISTICS;

EID: 0030503894     PISSN: 03233847     EISSN: None     Source Type: Journal    
DOI: 10.1002/bimj.4710380413     Document Type: Article

References (9)

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2. CHOW, S. C., 1992: Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker, Inc., New York.
3. CHOW, S. C. and SHAO, J., 1990: An alternative approach for the assessment of bioequivalence between two formulations of a drug. Biometrical J. 32, 969-976.
4. FDA, 1992: Guidance on Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design. The Division of Bioequivalence, Office of Generic Drugs, Food and Drug Administration, Rockville, Maryland.
5. FULLER, W. A., 1987: Measurement Error Models. John Wiley & Sons, New York, New York.
6. HAYNES, J. D., 1981: Statistical simulation study of new proposed uniformity requirement for bioequivalence studies. J. Pharm. Sciences 70, 673-675.
7. LIU, J. P., 1991: Bioequivalence and Intrasubject variability. J. Biopharm. Stat. 1, 205-219.
8. LIU, J. P. and CHOW, S. C., 1992: On the assessment of variability in bioavailability/bioequivalence studies. Comm. Stat. - Theory & Method. 21, 2591-2607.
9. MORGAN, W. A., 1939: A test for the significance of the difference between the two variances in a sample from a normal bivariate population. Biometrika 31, 13-19.