Related references
Note: Only part of the references are listed.Workshop Report: Crystal City VI-Bioanalytical Method Validation for Biomarkers
Mark E. Arnold et al.
AAPS JOURNAL (2016)
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2-Hybrid LBA/LCMS and input from regulatory agencies)
An Song et al.
BIOANALYSIS (2016)
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
Roger Hayes et al.
BIOANALYSIS (2016)
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2-hybrid LBA/LCMS and input from regulatory agencies)
Brad Ackermann et al.
BIOANALYSIS (2015)
Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance
Brian Booth et al.
AAPS JOURNAL (2015)
Stability: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Nico van de Merbel et al.
AAPS JOURNAL (2014)
2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2-hybrid LBA/LCMS, ELN & regulatory agencies' input)
Dawn Dufield et al.
BIOANALYSIS (2014)
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Mario Rocci et al.
BIOANALYSIS (2014)
8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation
Joseph Bower et al.
BIOANALYSIS (2014)
Recommendations on incurred sample stability (ISS) by GCC
Steve Lowes et al.
BIOANALYSIS (2014)
Recommendations on ISR in multi-analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)
Timothy Sangster et al.
BIOANALYSIS (2012)
6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Robert Nicholson et al.
BIOANALYSIS (2012)
4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover
Steve Lowes et al.
BIOANALYSIS (2012)
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Steve Lowes et al.
BIOANALYSIS (2012)
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Mark Boterman et al.
BIOANALYSIS (2012)
Recommendations on biomarker bioanalytical method validation by GCC
Richard Hougton et al.
BIOANALYSIS (2012)
The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum
Massimo Breda et al.
BIOANALYSIS (2011)
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
Steve Lowes et al.
BIOANALYSIS (2011)
Formation of a Global Contract Research Organization Council for Bioanalysis
Noel Premkumar et al.
BIOANALYSIS (2010)
2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop
Natasha Savoie et al.
BIOANALYSIS (2010)
Workshop/conference report - Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
C. T. Viswanathan et al.
AAPS JOURNAL (2007)
Share Paper
