2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines

General LC-MS/MS Method Approach to Quantify Therapeutic Monoclonal Antibodies Using a Common Whole Antibody Internal Standard with Application to Preclinical Studies

(2012) Hongyan Li et al.   ANALYTICAL CHEMISTRY

Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover

(2012) Steve Lowes et al.   Bioanalysis

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

(2012) Steve Lowes et al.   Bioanalysis

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

(2012) Mark Boterman et al.   Bioanalysis

Conference Report: The 1st Conference in Asia-Pacific on Recent Issues in Bioanalysis

(2011) Isabelle Dumont et al.   Bioanalysis

Oligonucleotide bioanalysis: sensitivity versus specificity

(2011) Laixin Wang   Bioanalysis

Utilization of electronic resources in the NDA/BLA regulatory review of bioanalytical data: perspectives from US FDA reviewers

(2011) Stanley Au et al.   Bioanalysis

Impact of sample hemolysis on drug stability in regulated bioanalysis

(2011) Eugénie-Raphaëlle Bérubé et al.   Bioanalysis

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

(2011) Fabio Garofolo et al.   Bioanalysis

Conference Report: The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum

(2011) Massimo Breda et al.   Bioanalysis

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

(2011) Steve Lowes et al.   Bioanalysis

Pellet digestion: a simple and efficient sample preparation technique for LC–MS/MS quantification of large therapeutic proteins in plasma

(2011) Zheng Ouyang et al.   Bioanalysis

International harmonization of bioanalytical guidance

(2010) Surendra K Bansal et al.   Bioanalysis

Formation of a Global Contract Research Organization Council for Bioanalysis

(2010) Noel Premkumar et al.   Bioanalysis

Building the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation

(2010) Peter van Amsterdam et al.   Bioanalysis

Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis

(2010) Philip Timmerman et al.   Bioanalysis

2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance

(2010) Natasha Savoie et al.   Bioanalysis

Workshop Report and Follow-Up—AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples—Implications of Crystal City Recommendations

(2009) Douglas M. Fast et al.   AAPS Journal

The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis

(2009) Natasha Savoie et al.   Bioanalysis

Society Spotlight: Spotlight on the Calibration and Validation Group

(2009) Wei Garofolo et al.   Bioanalysis

European Bioanalysis Forum and the way forward towards harmonized regulations

(2009) Berthold Lausecker et al.   Bioanalysis

2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

(2009) Natasha Savoie et al.   Bioanalysis