A parametric confidence interval for a moment-based scaled criterion for individual bioequivalence

Journal of Pharmacokinetics and Biopharmaceutics

Volumn 25, Issue 5, 1997, Pages 595-614

  Kimanani, Ebi K ^a   Potvin, Diane ^a  

^a Phoenix International Life Sciences ^*  (Canada)

Author keywords

Bioequivalence; Bootstrap; Moment based; Noncentral F distribution; Parametric confidence interval; Relative individual risk; Simulations; Weights

Indexed keywords

DRUG;

ARTICLE; BIOEQUIVALENCE; DATA ANALYSIS; DRUG FORMULATION; PRIORITY JOURNAL; PROBABILITY; SIMULATION; STATISTICS; STOCHASTIC MODEL;

COMPUTER SIMULATION; CONFIDENCE INTERVALS; HUMANS; MODELS, STATISTICAL; PROBABILITY; RISK; THERAPEUTIC EQUIVALENCY;

EID: 0031396991     PISSN: 0090466X     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1025717414526     Document Type: Article

References (10)

1. R. Schall and R. L. Williams. Towards a practical strategy for assessing individual bioequivalence. J. Pharmacokin. Biopharm. 24:133-148 (1996).
2. S. Anderson and W. W. Hauck. Consideration of individual bioequivalence. J. Pharmacokin. Biopharm. 18:259-273 (1990).
3. S. Anderson and W. W. Hauck. Measuring switchability and prescribability: when is average bioequivalence sufficient? J. Pharmacokin. Biopharm. 22:551-564 (1994).
4. R. Schall and H. G. Luus. On population and individual bioequivalence. Stat. Med. 12:1109-1124 (1993).
5. L. B. Sheiner. Bioequivalence revisited. Statist. Med. 11:1777-1788 (1992).
6. G. Ekbohm and H. Melander. The subject-by-formulation interaction as a criterion of interchangeability of drugs. Biometrics 45:1249-1254 (1990).
7. L. Endrenyi. A simple approach for the evaluation of individual bioequivalence. Drug Inform. J. 29:847-855 (1995).
8. D. J. Holder and F. Hsuan. Moment-based criteria for determining bioequivalence. Biometrika 80:835-846 (1993).
9. H. Schaffé. The Analysis of Variance, Wiley, New York (1959).
10. B. Efron and R. J. Tibshirani. An Introduction to the Bootstrap, Chapman and Hall, New York, 1993.