Journal
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Volume 877, Issue 23, Pages 2208-2213Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jchromb.2009.01.027
Keywords
Assay; Equivalence; Acceptance limits; Confidence interval; Tolerance interval; Probability
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At any phase of the development of a drug or a vaccine, scientists need to compare different (bio)assays. The objective of this paper is to review different statistical methodologies that could be used to assess the equivalence between methods. Depending on the objective (average or individual equivalence), depending on the design, several approaches are detailed: two one-sided t-tests, concordance correlation coefficient. limits of agreement, tolerance intervals and probabilistic approach. (C) 2009 Elsevier B.V. All rights reserved.
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