Mikaël Le Bouter on Muck Rack

Mikaël Le Bouter

As seen in: Taylor & Francis Online
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Articles

Assessing linearity of vaccine immunogenicity assays: application and link with clinical endpoints

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By Aurélie Bellanger, Oana Petrof, Martin Verniquet, Mikaël Le Bouter
| Taylor & Francis Online
ABSTRACT Assessing the performance of an immunogenicity assay before using it to support vaccine clinical trials is mandatory. Further validation of assay performance is even requested to support Phase III studies. While assay validation requires adherence to predefined acceptance criteria, there is no universal stringency level for earlier phases of assay development.
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