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Inference of bioequivalence for log-normal distributed data with unspecified variances

  • Published:2014-01-09 Issue:17 Volume:33 Page:2924-2938
  • ISSN:0277-6715
  • Container-title:Statistics in Medicine
  • language:en
  • Short-container-title:Statist. Med.

Author:

Xu Siyan1,Hua Steven Y.2,Menton Ronald2,Barker Kerry2,Menon Sandeep13,D'Agostino Ralph B.14

Affiliation:

1. Biostatistics; Boston University School of Public Health; 801 Massachusetts Avenue Boston MA 02118 U.S.A.

2. Biotechnology Clinical Development; Pfizer Inc.; 35 Cambridgepark Dr. Cambridge MA 02140 U.S.A.

3. Bio-therapeutics Clinical Research; Pfizer Inc.; 35 Cambridgepark Dr. Cambridge MA 02140 U.S.A.

4. Boston University Mathematics and Statistics Department; 111 Cummington Street Boston MA 02215 U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference21 articles.

1. FDA Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products- General Considerations 2003

2. Bioavailability-a problem in equivalence;Metzler;Biometrics,1974

3. Bioequivalence testing: a need to rethink (reader reaction);Kirkwood;Biometrics,1981

4. Symmetric confidence intervals for bioequivalence trials;Westlake;Biometrics,1976

5. A new procedure for testing equivalence in comparative bioavailability and other clinical trials;Anderson;Communications in Statistics-Theory and Methods,1983

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