131
Views
13
CrossRef citations to date
0
Altmetric
Original Articles

Examining Outlying Subjects and Outlying Records in Bioequivalence Trials

&
Pages 43-56 | Published online: 16 Aug 2006

REFERENCES

  • Anderson , S. and Hauck , W. W. 1990 . Consideration of individual bioequivalence . Journal of Pharmacokinetics and Biopharmaceutics , 18 ( 2 ) : 59 – 273 .
  • Beckman , R. J. and Cook , R. D. 1983 . Outlier...s (with discussion) . Technometrics , 25 : 119 – 163 .
  • in press .
  • Chow , S. C. and Tse , S. K. 1990 . Outlier detection in bioavailability/bioequivalence studies . Stat. Med. , 9 : 549 – 558 .
  • Cook , R. D. 1977 . Detection of influential observations in linear regression . Technometrics , 19 : 15 – 18 .
  • Cook , R. D. and Weisberg , S. 1980 . Characterization of an empirical influence function for detecting influential cases in regression . Technometrics , 22 : 495 – 508 .
  • Cox , D. R. and Hinkley , D. V. 1974 . Theoretical statistics Chapman & Hall .
  • 2000 . Guideline for Industry: Bioavailability and Bioequivalence Study for Orally Administered Drug Products—General Considerations Rockville, Maryland : Center for Drug Evaluation and Research, Food and Drug Administration .
  • Ferguson , T. S. 1961 . “ On the rejection of outliers ” . In Proceedings of the fourth Berkeley symposium on mathematical statistics and probability (Vol. 1) 253 – 287 . Berkeley and Los Angeles : University of California Press .
  • Ferguson , T. S. 1967 . Mathematical statistics: a decision theoretic approach New York : Academic Press .
  • Hawkins , D. M. 1980 . Identifications of outliers Chapman & Hall .
  • Liu , J. P. and Weng , C. S. 1991 . Detection of outlying data in bioavailability/bioequivalence studies . Stat. Med. , 10 : 1375 – 1389 .
  • Metzler , C. M. and Huang , D. C. 1983 . Statistical methods for bioavailability and bioequivalence . Clin. Res. Prac. Drug Regulat. Affairs , 1 : 109 – 132 .
  • O'Brien , P. C. 1984 . Procedures for comparing samples with multiple endpoints . Biometrics , 40 : 1079 – 1087 .
  • Schuirman , D. J. 1987 . A comparision of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability . Journal of Pharmacokinetics and Biopharmaceutics , 15 : 657 – 680 .
  • Srikantan , K. S. 1961 . Testing a single outlier in a regression model . Sankhyā. Ser. A , 23 : 251 – 260 .
  • Westlake , W. J. 1976 . Symmetrical confidence intervals for bioequivalence trials. . Biometrics , 32 : 741 – 744 .

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.