Sample Size Considerations for Assessing Vaccine Consistency through Equivalence

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 nom...

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Bibliographic Details
Published in:Drug information journal 1999, Vol.33 (1), p.149-151
Main Authors: Cheuvart, Brigitte, Bollaerts, Anne
Format: Article
Language:English
Subjects:
Biological and medical sciences
Consistency
Equivalence
Immunomodulators
Medical sciences
Pharmacology. Drug treatments
Vaccines
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Summary: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.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286159903300117