Key elements of bioanalytical method validation for macromolecules

Measuring agreement in method comparison studies

Martin Bland, D.G. Altman · Statistical Methods in Medical Research · 1999 · 2.8K citations

Pharmacy, Educational Measurement, Method Validation +8

Bioanalytical Method Validation—A Revisit with a Decade of Progress

Vinod P. Shah, Kamal K. Midha, John W. A. Findlay et al. · Pharmaceutical Research · 2000 · 1.6K citations

Pharmacy, Biochemistry, Analytical Chemistry +11

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 · 614 citations

Pharmacy, Clinical Pharmacokinetics, Pharmacokinetics +14

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 · 582 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutics +11

ELISA Guidebook, The

John R. Crowther · Humana Press eBooks · 2000 · 511 citations

Life Sciences, Immunology, Biosensors +15