Concepedia

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

Lauren Stevenson, Marian Kelley, Boris Gorovits, Clare Kingsley, Heather Myler, Karolina Österlund, Arumugam Muruganandam, Yoshiyuki Minamide, M. Domínguez

The AAPS Journal · 2013 · 25 citations · 16 references

DOI

Concepts

References

16

Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules

Binodh DeSilva, Wendell C. Smith, Russell Weiner et al. · Pharmaceutical Research · 2003 · 614 citations

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Interferences in immunoassay.

Jill Tate, Greg Ward · PubMed · 2004 · 430 citations

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A QUANTITATIVE THEORY OF THE PRECIPITIN REACTION

Michael Heidelberger, Forrest E. Kendall · The Journal of Experimental Medicine · 1935 · 349 citations · Full text

, , +14

European Medicines Agency Guideline on Bioanalytical Method Validation: What More Is There to Say?

G. T. Smith · Bioanalysis · 2012 · 307 citations

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Potential aggregation prone regions in biotherapeutics

Xiaoling Wang, Tapan K. Das, Satish Kumar Singh et al. · mAbs · 2009 · 195 citations · Full text

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