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Original Articles

Sample Size Adaptation in Fixed-Dose Combination Drug Trial

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Pages 679-686 | Received 19 Feb 2011, Accepted 28 Jan 2012, Published online: 31 May 2012

REFERENCES

  • Bauer , P. , Köhne , K. ( 1994 ). Evaluations of experiments with adaptive interim analyses . Biometrics 50 : 1029 – 1041 .
  • Cui , L. , Hung , H. M. J. , Wang , S. J. ( 1999 ). Modification of sample size in group sequential clinical trials . Biometrics 55 : 321 – 324 .
  • Food and Drug Administration. (2010a). Draft guidance document on adaptive design clinical trials for drug or biologics. February. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf
  • Food and Drug Administration. (2010b). Draft guidance document on codevelopment for two or more unmarketed investigational drugs for use in combination. December. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM236669.pdf
  • Gould , A. L. , Shih , W. J. ( 1992 ). Sample size reestimation without unblinding for normally distributed outcomes with unknown variance . Communications in Statistics (A)—Theory and Methods 21 ( 10 ): 2833 – 2853 .
  • Hung , H. M. J. , Wang , S. J. ( 2009 ). Some controversial multiple testing problems in regulatory applications . Journal of Biopharmaceutical Statistics 19 : 1 – 11 .
  • Laska , E. M. , Meisner , M. J. ( 1989 ). Testing whether an identified treatment is best . Biometrics 45 : 1139 – 1151 .
  • Liu , Q. , Anderson , K. M. ( 2008 ). On adaptive extensions of group sequential trials for clinical investigations . Journal of the American Statistical Association 103 : 1621 – 1630 .

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