articleTop 1% cited
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
Journal of Immunological Methods · 2004 · Vol. 289(1-2) · pp. 1–16
Anthony R. Mire‐Sluis✉(Center for Drug Evaluation and Research)Yu Chen Barrett(Bristol-Myers Squibb (United States))Viswanath Devanarayan(Eli Lilly (United States))Eugen Koren(Amgen (United States))Hank LiuMauricio Maia(PDL BioPharma (United States))Thomas ParishG. H. ScottGopi ShankarElizabeth W. ShoresSteven J. Swanson(Amgen (United States))Gary T. Taniguchi(BioMarin (United States))Daniel Wierda(Eli Lilly (United States))Linda A. Zuckerman
Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsBiotin and Related StudiesImmunogenicityBiopharmaceuticalLicensureAntibodyAntibody responseImmunoassayComputational biologyBiotechnologyMedicineBiochemical engineering
MeSH terms
AntibodiesBiological ProductsBiotechnologyHumansImmunoassayDrug-Related Side Effects and Adverse Reactions
Citations
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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
Journal of Pharmaceutical and Biomedical Analysis · 2008 · 596 citations
References
Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective
Journal of Pharmaceutical and Biomedical Analysis · 2000 · 578 citations
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