The aim of a consistency study is to prove equivalence between multiple pairs of production batches. In this paper it is shown that an adequate overall power to conclude consistency can be achieved by using the principle of Bonferroni adjustment on the type II error. Simulations suggest that the nominal alpha level for pairwise comparison of batches can be increased above 0.05 in order to maintain the overall type I error of concluding false consistency below 0.05.
CBER.Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Disease: Production, Testing, and Clinical Studies. Rockville, MD: U.S. Food and Drug Administration; April 1997.
2.
BlackwelderWCProving the null hypothesis in clinical trials. Controll Clin Trials.1982;3:345–353.
3.
DunnettCWTamhaneACMultiple testing to establish superiority/equivalence of a new treatment compared with k standard treatments. Stat Med.1997;16: 2489–2506.
4.
CapizziTZhangJ.Testing the hypothesis that matters for multiple primary endpoints. Drug Inf J.1996;30: 949–956.
5.
KochGGGanskySAStatistical considerations for multiplicity in confirmatory protocols. Drug Inf J.1996;30:523–534.
6.
DunnetCWGentM.An alternative to the use of two-sided tests in clinical trials. Stat Med.1996;15: 1729–1738.
7.
ElashoffJDnQuery Advisor Version 2.0 User's Guide. Los Angeles CA: Dixon Associates; 1997.
