An alternative definition of individual bioequivalence

Statistica Neerlandica

Volumn 54, Issue 1, 2000, Pages 14-36

  Longford, Nicholas T ^a  

^a DE MONTFORT UNIVERSITY   (United Kingdom)

Author keywords

Heterogeneity; Latent variable; Measurement error; Treatment; Variance components

Indexed keywords

EID: 0034348930     PISSN: 00390402     EISSN: None     Source Type: Journal    
DOI: 10.1111/1467-9574.00123     Document Type: Article

References (13)

1. ANDERSON, S. and W. W. HAUCK (1990), Consideration of individual bioequivalence, Journal of Pharmacokinetics and Biopharmaceutics 18, 259-274.
2. BROWN, E. B., H. K. IYER and C. M. WANG (1997), Tolerance intervals for assessing individual bioequivalence, Statistics in Medicine 16, 803-820.
3. CHI, E. M. (1994), M-estimation in cross-over trials, Biometrics 50, 486-493.
4. EFRON, B. and R. J. TIBSHIRANI (1993), An introduction to the bootstrap, Chapman and Hall, New York, NY.
5. ESINHART, J. D. and V. M. CHINCHILI (1994), Extension to the use of tolerance intervals for the assessment of individual bioequivalence, Journal of Biopharmaceutical Statistics 4, 39-52.
6. FOOD AND DRUG ADMINISTRATION (1992), Guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design. Division of Bioquivalence, Office of Generic Drugs, Center for Drug Evaluation Research, Food and Drug Administration, Rockville, MD.
7. FOOD AND DRUG ADMINISTRATION (1997), Guidance for industry. In vivo bioequivalence studies based on population and individual bioequivalence approaches. Draft guidance. U.S. Department of Health and Human Services, Washington, DC.
8. HAUCK, W. W., M.-L. CHEN, T. HYSLOP, R. PATNAIK, D. SCHUIRMAN and R. WILLIAMS FOR THE FOOD AND DRUG ADMINISTRATION INDIVIDUAL BIOEQUIVALENCE WORKING GROUP (1996), Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence, International Journal of Clinical Pharmacology and Therapeutics 34, 535-541.
9. LINDLEY, D. V. (1998), Decision analysis and bioequivalence trials, Statistical Science 13, 136-141.
10. SCHALL, R. (1995), Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar, Biometrics 51, 615-626.
11. SCHALL, R. and R. L. WILLIAMS FOR THE FOOD AND DRUG ADMINISTRATION INDIVIDUAL BIOEQUIVALENCE WORKING GROUP (1996), Towards a practical strategy for assessing individual bioequivalence, Journal of Pharmacokinetics and Biopharmaceutics 24, 133-149.
12. SENN, S. J. (1998), In the blood: Proposed new requirements for registering generic drugs, The Lancet 352, 85-86.
13. SPECIAL ISSUE ON BIOAVAILABILITY/BIOEQUIVALENCE (1997), Journal of Biopharmaceutical Statistics 7, 1-204.