210
Views
2
CrossRef citations to date
0
Altmetric
Original Articles

Bridging Bioequivalence Studies

Pages 857-867 | Received 01 Dec 2003, Accepted 01 Jan 2004, Published online: 02 Feb 2007

References

  • Chow , S. C. and Liu , J. P. 1997 . Meta-analysis for bioequivalence review . J. Biopharmaceut. Statist. , 7 : 97 – 111 .
  • Chow , S. C. and Liu , J. P. 2000 . Design and Analysis of Bioavailability and Bioequivalence , 2nd ed. Revised and Expanded New York : Marcel Dekker, Inc .
  • Cochran , W. G. and Cox , G. M. 1950 . Experimental Design New York : Wiley .
  • Fleming , T. R. 2000 . Design and interpretation of equivalence trials . Am. Heart J. , 139 : S172 – S176 .
  • ICH E5. 1998 . “ Ethnic Factors in the Acceptability of Foreign Data ” . In International Conference on Harmonization Tripartite Guidance E5 Vol. 83 , 31,790 – 31,796 . The U.S. Federal_Register .
  • Liu , J. P. , Hsueh , M. M. and Chen , J. J. 2002a . Sample size requirements for evaluation of bridging evidence . Biometric. J. , 44 : 969 – 981 .
  • Liu , J. P. , Hsiao , C. F. and Hsueh , H. M. 2002b . Bayesian approach to evaluation of bridging studies . J. Biopharmaceut. Stat. , 12 : 287 – 294 .
  • Rothmann , M. , Li , N. , Chen , G. , Chi , G. Y. H. , Temple , R. and Tsou , H. H. 2003 . Design and analysis of non-inferiority mortality trials in oncology . Statist. Med. , 22 : 239 – 264 .
  • The US FDA . 2003 . Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug products – General Considerations Rockville, Maryland : The U.S. Food and Drug Administration .
  • Wang , S. J. , Hung , J. H. M. and Tsong , Y. 2002 . Utility and pitfalls of some statistical methods in active control trials . Control. Clin. Trials , 23 : 15 – 28 .
  • Wang , S. J. and Hung , J. H. M. 2003 . TACT method for noninferiority testing in active controlled trials . Statist. Med. , 22 : 227 – 238 .
  • #The views expressed in this article are personal opinions of the authors and may not necessarily represent the position of National Taiwan University, Taiwan.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.