Concepedia

Harmonization of strategies for the validation of quantitative analytical procedures

Ph. Hubert, J.-J. Nguyen-Huu, Bruno Boulanger, E. Chapuzet, Patrice Chiap, Nadine Cohen, P.-A. Compagnon, Walthère Dewé, Max Feinberg, M. Lallier,

Journal of Pharmaceutical and Biomedical Analysis · 2004 · 163 citations · 38 references

DOI

Concepts

References

38

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

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Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies

Vinod P. Shah, Kamal K. Midha, Shrikant V. Dighe et al. · Journal of Pharmaceutical Sciences · 1992 · 1.1K citations

, , +14

Synthesis of Variance

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

, , +11

Guidance for robustness/ruggedness tests in method validation

Yvan Vander Heyden, Arend Nijhuis, J. Smeyers–Verbeke et al. · Journal of Pharmaceutical and Biomedical Analysis · 2001 · 630 citations

, , +9

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

, , +11