articleTop 1% cited
Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
Pharmaceutical Research · 2007 · Vol. 24(10) · pp. 1962–1973
C.T. Viswanathan✉Surendra K. Bansal(La Roche College)Brian Booth(Center for Drug Evaluation and Research)Anthony J. DeStefano(Procter & Gamble (United States))Mark J. Rose(Amgen (United States))Jeffrey Sailstad(Durham University)Vinod P. ShahJerome P. SkellyPatrick G. Swann(Center for Drug Evaluation and Research)Russell Weiner(Bristol-Myers Squibb (Germany))
Biosimilars and Bioanalytical MethodsAdvanced Biosensing Techniques and ApplicationsClinical Laboratory Practices and Quality ControlBioanalysisChromatographyChemistryLigand (biochemistry)Computational biologyBiochemistryBiologyReceptor
MeSH terms
AnimalsBiological AssayBody FluidsCalibrationChromatographyDocumentationDrug StabilityHumansQuality ControlRadioligand AssayReference StandardsSpecies SpecificityTechnology, PharmaceuticalUnited StatesUnited States Food and Drug Administration
Citations
813
FWCI
17.07
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4
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99%
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References
Bioanalytical Method Validation—A Revisit with a Decade of Progress
Pharmaceutical Research · 2000 · 1,565 citations
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Journal of Pharmaceutical Sciences · 1992 · 1,129 citations
Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Pharmaceutical Research · 2003 · 610 citations
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