Recommendations on Biomarker Bioanalytical Method Validation By Gcc

Richard Hougton, Dominique Gouty, John Allinson, +25

Bioanalysis

Cro LeadersEngineeringPathologyVerification And ValidationUnique Opportunity +17

Simultaneous quantification of atomoxetine as well as its primary oxidative and O-glucuronide metabolites in human plasma and urine using liquid chromatography tandem mass spectrometry (LC/MS/MS)

J.H. Mullen, R. Shugert, G. Douglas Ponsler, +8

Journal of Pharmaceutical and Biomedical Analysis

BiochemistryGas ChromatographyMedicineBioanalysisMass Spectrometry +11

Recommendations on Incurred Sample Stability (ISS) by GCC

Steve Lowes, Richard LeLacheur, Ronald E. Shoup, +42

Bioanalysis

EngineeringSample TreatmentRobustness TestingSoftware AnalysisPerformance Portability +23

Recommendations on Bioanalytical Method Stability Implications of Co-Administered And Co-Formulated Drugs By Global Cro Council For Bioanalysis (Gcc)

Steve Lowes, Mark Boterman, Mira Doig, +87

Bioanalysis

Pharmaceutical ScienceGlobal Cro CouncilCo-formulated DrugsBioanalysisStability Data +17

8th GCC: Consolidated Feedback to US FDA on The 2013 Draft FDA Guidance on Bioanalytical Method Validation

Joseph Bower, Douglas M. Fast, Fabio Garofolo, +59

Bioanalysis

EngineeringVerification And ValidationConsolidated FeedbackTranslational MedicineProcess Analytical Technology +14

Conference Report: 6Th Gcc Focus on Lba: Critical Reagents, Positive Controls And Reference Standards; Specificity For Endogenous Compounds; Biomarkers; Biosimilars

Robert I. Nicholson, Steve Lowes, Maria Cruz Caturla, +42

Bioanalysis

Global Cro CouncilEngineeringReagentPre-clinical PharmacologyConference Report +24

Small Molecule Specific Run Acceptance, Specific Assay Operation, and Chromatographic Run Quality Assessment: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Teams

Eric Woolf, Stuart McDougall, Douglas M. Fast, +27

The AAPS Journal

MedicineBioanalysisPharmacologyAnalytical ChemistryBiostatistics +9

7th GCC Insights: Incurred Samples Use; Fit-For-Purpose Validation, Solution Stability, Electronic Laboratory Notebook and Hyperlipidemic Matrix Testing

Mario L. Rocci, Steve Lowes, Ronald E. Shoup, +41

Bioanalysis

EngineeringMeasurementEducationVerification And ValidationCalibration +14

9th GCC Closed Forum: Capa in Regulated Bioanalysis; Method Robustness, Biosimilars, Preclinical Method Validation, Endogenous Biomarkers, Whole Blood Stability, Regulatory Audit Experiences and Electronic Laboratory Notebooks

Richard LeLacheur, Isabelle Dumont, Philippe Couerbe, +56

Bioanalysis

EngineeringElectronic Laboratory NotebooksBiomarker (Medicine)Translational MedicineBiobank +22