reviewTop 10% cited

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

Journal of Pharmaceutical and Biomedical Analysis · 2008 · Vol. 48(5) · pp. 1267–1281

Gopi ShankarViswanath Devanarayan(Abbott Fund)Lakshmi Amaravadi(Biogen (United States))Yu Chen Barrett(Bristol-Myers Squibb (United States))Ronald R. BowsherDeborah Finco‐Kent(Pfizer (United States))Michele Fiscella(Human Genome Sciences (United States))Boris Gorovits(Pearl River Community College)Susan Kirschner(United States Food and Drug Administration)Michael Moxness(Amgen (United States))Thomas Parish(Procter & Gamble (United States))Valerie QuarmbyHolly W. Smith(Eli Lilly (United States))Wendell C. SmithLinda A. ZuckermanEugen Koren✉(Abbott (United States))

View via DOI Publisher page

Biosimilars and Bioanalytical Methods Monoclonal and Polyclonal Antibodies Research Protein purification and stabilityImmunogenicityMarketing authorizationDrugAuthorizationComputational biologyBiochemical engineeringPharmacologyRisk analysis (engineering)MedicineComputer science

MeSH terms

AnimalsAntibodiesBiological ProductsBiotechnologyHealth Planning GuidelinesHumansImmunoassayReproducibility of ResultsDrug-Related Side Effects and Adverse Reactions

Citations

596

FWCI

8.34

field-weighted impact

References

Percentile

98%

vs. same field & year

Citations per year

References

Antibodies, a laboratory manual

Biomedicine & Pharmacotherapy · 1989 · 12,466 citations

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

Journal of Pharmaceutical and Biomedical Analysis · 2000 · 578 citations

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

Journal of Immunological Methods · 2004 · 618 citations

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

Pharmaceutical Research · 2003 · 610 citations

Factors influencing the immunogenicity of therapeutic proteins

Nephrology Dialysis Transplantation · 2005 · 329 citations

Antibodies: A laboratory manual

Trends in Biochemical Sciences · 1989 · 5,154 citations

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