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Harmonization of strategies for the validation of quantitative analytical procedures

Journal of Pharmaceutical and Biomedical Analysis · 2007 · Vol. 45(1) · pp. 70–81
P. HubertJ.-J. Nguyen-HuuBruno BoulangerE. ChapuzetPatrice ChiapNadine CohenP.-A. CompagnonWalthère DewéMax FeinbergM. LallierMichel LaurentieNorbert MercierG. MuzardC. NivetL. ValatEric Rozet
Pesticide Residue Analysis and SafetyAnalytical Methods in PharmaceuticalsStatistical Methods in Clinical TrialsHarmonizationTerminologyContext (archaeology)Reliability (semiconductor)Quality (philosophy)Management scienceComputer scienceCommissionRisk analysis (engineering)Engineering

MeSH terms

CalibrationChemistry Techniques, AnalyticalChemistry, PharmaceuticalFranceReference StandardsSocieties, MedicalReproducibility of ResultsClinical Laboratory Techniques
Citations
539
FWCI
43.43
field-weighted impact
References
53
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100%
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Cited by
Harmonization of strategies for the validation of quantitative analytical procedures
Journal of Pharmaceutical and Biomedical Analysis · 2007 · 325 citations
References
Bioanalytical Method Validation—A Revisit with a Decade of Progress
Pharmaceutical Research · 2000 · 1,565 citations
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Journal of Pharmaceutical Sciences · 1992 · 1,129 citations
Validation of bioanalytical chromatographic methods
Journal of Pharmaceutical and Biomedical Analysis · 1998 · 309 citations
Validation in pharmaceutical analysis. Part I: An integrated approach
Journal of Pharmaceutical and Biomedical Analysis · 2001 · 254 citations
Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective
Journal of Pharmaceutical and Biomedical Analysis · 2000 · 578 citations
Guidance for robustness/ruggedness tests in method validation
Journal of Pharmaceutical and Biomedical Analysis · 2001 · 624 citations
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