Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 1
Abstract
The L2 Global Harmonization Team on large molecule specific assay operation for protein bioanalysis in support of pharmacokinetics focused on the following topics: setting up a balanced validation design, specificity testing, selectivity testing, dilutional linearity, hook effect, parallelism, and testing of robustness and ruggedness. The team additionally considered the impact of lipemia, hemolysis, and the presence of endogenous analyte on selectivity assessments as well as the occurrence of hook effect in study samples when no hook effect had been observed during pre-study validation.
Authors and Affiliations
Lauren Stevenson, Marian Kelley, Boris Gorovits, Clare Kingsley, Heather Myler, Karolina Österlund, Arumugam Muruganandam, Yoshiyuki Minamide, Mario Dominguez
Keywords
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- EP ID EP681053
- DOI 10.1208/s12248-013-9542-y
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