Analysis of recent pharmaceutical regulatory documents on analytical method validation

Eric Rozet, Attilio Ceccato, Cédric Hubert, +5

Journal of Chromatography A

Method ValidationMedicinal ChemistryBioequivalenceDrug PurityDrug Discovery +9

Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space

Benjamin Debrus, Pierre Lebrun, Jérémie Mbinze Kindenge, +8

Journal of Chromatography A

Medicinal ChemistryGas ChromatographyDrug DiscoveryBioanalysisMalaria +12

Application of new methodologies based on design of experiments, independent component analysis and design space for robust optimization in liquid chromatography

Benjamin Debrus, Pierre Lebrun, Attilio Ceccato, +8

Analytica Chimica Acta

EngineeringSeparation ScienceGas ChromatographyProcess Analytical TechnologyBioanalysis +12

Enantiomeric determination of tramadol and its main metabolite O-desmethyltramadol in human plasma by liquid chromatography–tandem mass spectrometry

Attilio Ceccato, Francis Vanderbist, J.-Y Pabst, +1

Journal of Chromatography B Biomedical Sciences and Applications

Pharmacological StudyBiochemistryMedicineBioanalysisMass Spectrometry +8

Using tolerance intervals in pre-study validation of analytical methods to predict in-study results

Eric Rozet, Cédric Hubert, Attilio Ceccato, +8

Journal of Chromatography A

ReliabilityMethod ValidationMethodological DevelopmentEngineeringTolerance Intervals +9

Development of a new predictive modelling technique to find with confidence equivalence zone and design space of chromatographic analytical methods

Pierre Lebrun, Bernadette Govaerts, Benjamin Debrus, +4

Chemometrics and Intelligent Laboratory Systems

Method ValidationEngineeringPharmacokinetic ModelingUncertainty QuantificationMedicine +13

Enantiomeric determination of amlodipine in human plasma by liquid chromatography coupled to tandem mass spectrometry

Bruno Streel, C Lainé, Collin Zimmer, +2

Journal of Biochemical and Biophysical Methods

Gas ChromatographyMedicineBioanalysisMass SpectrometryPhysiology +10

Sensitive determination of buprenorphine and its N-dealkylated metabolite norbuprenorphine in human plasma by liquid chromatography coupled to tandem mass spectrometry

Attilio Ceccato, Régis Klinkenberg, Ph. Hubert, +1

Journal of Pharmaceutical and Biomedical Analysis

BiochemistryGas ChromatographyMedicineDrug PurityBioanalysis +8

Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces

Régis Klinkenberg, Bruno Streel, Attilio Ceccato

Journal of Pharmaceutical and Biomedical Analysis

Residue (Chemistry)Gas ChromatographyManufacturing Equipment SurfacesMedicineDrug Purity +10

Automated determination of tramadol enantiomers in human plasma using solid-phase extraction in combination with chiral liquid chromatography

Attilio Ceccato, Patrice Chiap, Ph. Hubert, +1

Journal of Chromatography B Biomedical Sciences and Applications

Chiral Liquid ChromatographyMedicineHuman PlasmaTramadol EnantiomersAnalytical Chemistry +5