article
Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Pharmaceutical Research · 2003 · Vol. 20(11) · pp. 1885–1900
Binodh DeSilva✉(Amgen (United States))Wendell C. Smith(Greenfield Research (Canada))Russell Weiner(Bristol-Myers Squibb (Sweden))Marian Kelley(Johnson & Johnson (United States))JoMarie SmolecBenjamin Lee(Pfizer (United States))Masood Mehmood Khan(Covance (United States))Richard Tacey(Pharmaceutical Product Development (United States))Howard HillAbbie Celniker(Millennium Engineering and Integration (United States))
Biosimilars and Bioanalytical MethodsAdvanced Biosensing Techniques and ApplicationsComputational Drug Discovery MethodsBioanalysisAcceptance testingComputer scienceProcess (computing)Biochemical engineeringComputational biologyChemistryEngineeringChromatographyBiology
MeSH terms
Carrier ProteinsPharmaceutical PreparationsLigandsRadioligand AssayReproducibility of ResultsMacromolecular Substances
Funding
- Eli Lilly and Company
- American Association of Pharmaceutical Scientists
Citations
610
FWCI
2.15
field-weighted impact
References
20
Percentile
88%
vs. same field & year
Citations per year
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References
Bioanalytical Method Validation—A Revisit with a Decade of Progress
Pharmaceutical Research · 2000 · 1,565 citations
THE DESIGN OF OPTIMUM MULTIFACTORIAL EXPERIMENTS
Biometrika · 1946 · 3,783 citations
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Journal of Pharmaceutical Sciences · 1992 · 1,129 citations
Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective
Journal of Pharmaceutical and Biomedical Analysis · 2000 · 578 citations
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