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Large Molecule Specific Assay Operation: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

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 t...

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Dettagli Bibliografici
Autori principali: Stevenson, Lauren, Kelley, Marian, Gorovits, Boris, Kingsley, Clare, Myler, Heather, Österlund, Karolina, Muruganandam, Arumugam, Minamide, Yoshiyuki, Dominguez, Mario
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer US 2013
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Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC3889533/
https://ncbi.nlm.nih.gov/pubmed/24242296
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9542-y
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