Summary of Confirmation Cut Point Discussions
Journal Title: The AAPS Journal - Year 2011, Vol 13, Issue 2
Abstract
A subgroup of AAPS NBC Immunogenicity Workshop attendees met to discuss the current recommendations in white papers and guidance documents, to describe and discuss current practices, and to resolve concerns as to the biologically and statistically appropriate approaches to determining a confirmatory cut point for immunogenicity assays. This is a summary of our discussions and recommendations.
Authors and Affiliations
Holly W. Smith, Michael Moxness, Robin Marsden
Keywords
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