Concepedia

Analysis of recent pharmaceutical regulatory documents on analytical method validation

Eric Rozet, Attilio Ceccato, Cédric Hubert, Eric Ziémons, Radu Oprean, Serge Rudaz, Bruno Boulanger, Philippe Hubert

Journal of Chromatography A · 2007 · 268 citations · 32 references

DOI

Concepts

References

32

Compendium of chemical terminology

Victor Gold · 1987 · 2.5K citations

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Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)

Michael Thompson, Stephen L. R. Ellison, Roger Wood · Pure and Applied Chemistry · 2002 · 2.4K citations · Full text

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Synthesis of Variance

F. E. Satterthwaite · Psychometrika · 1941 · 827 citations

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Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

Jean W. Lee, Viswanath Devanarayan, Yu Chen Barrett et al. · Pharmaceutical Research · 2006 · 759 citations

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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

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