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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Detalhes bibliográficos
Main Authors: Stevenson, Lauren, Kelley, Marian, Gorovits, Boris, Kingsley, Clare, Myler, Heather, Österlund, Karolina, Muruganandam, Arumugam, Minamide, Yoshiyuki, Dominguez, Mario
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2013
Assuntos:
White Paper
Acesso em linha: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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