Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
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Abstract | :
European Bioanalysis Forum Workshop, Lisbon, Spain, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the bioanalytical community in relation to immunogenicity assays were discussed through a mixture of presentations and panel sessions. The main areas of focus were the evolving regulatory landscape, challenges of assay interferences from either drug or target, cut-point setting and whether alternative assays can be used to replace neutralizing antibody assays. This workshop report captures discussions and potential solutions and/or recommendations made by the speakers and delegates. |
Year of Publication | :
2018
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Journal | :
Bioanalysis
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Date Published | :
2018
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ISSN Number | :
1757-6180
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URL | :
http://www.future-science.com/doi/full/10.4155/bio-2017-4971?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
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DOI | :
10.4155/bio-2017-4971
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Short Title | :
Bioanalysis
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