A Total Error Approach for the Validation of Quantitative Analytical Methods

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 · 610 citations

Molecular Docking, Ligand-binding Assays, Pharmacokinetic Modeling +11

Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective

John W. A. Findlay, W. Smith, J.W. Lee et al. · Journal of Pharmaceutical and Biomedical Analysis · 2000 · 577 citations

Pharmaceutical Industry Perspective, Bioanalysis, Immunology +7

Harmonization of strategies for the validation of quantitative analytical procedures

P. Hubert, J.-J. Nguyen-Huu, Bruno Boulanger et al. · Journal of Pharmaceutical and Biomedical Analysis · 2007 · 539 citations

Reliability, Method Validation, Methodological Development +11

Tolerance Limits for a Normal Distribution

Abraham Wald, J. Wolfowitz · The Annals of Mathematical Statistics · 1946 · 218 citations · Full text

Large Deviations, Approximate Tolerance Limits, Engineering +6

Harmonization of strategies for the validation of quantitative analytical procedures

Ph. Hubert, J.-J. Nguyen-Huu, Bruno Boulanger et al. · Journal of Pharmaceutical and Biomedical Analysis · 2004 · 161 citations

Reliability, Method Validation, Methodological Development +11