Dominique Gouty

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2 Bioanalytical report writing

Kevin Bateman, Roger Hayes, Eric Woolf, 2022 .

Design of bioanalytical testing used in comparability studies for Biosimilars

Dominique Gouty, 2011 .

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Stacy Ho, Eric Woolf, Binodh DeSilva, 2011, Bioanalysis.

2013 White Paper on recent issues in bioanalysis: 'hybrid'--the best of LBA and LCMS.

Stacy Ho, Roger Hayes, Eric Woolf, 2013, Bioanalysis.

Formation of a Global Contract Research Organization Council for Bioanalysis.

Xinping Fang, Fabio Garofolo, Chad Briscoe, 2010, Bioanalysis.

Recommendations on incurred sample stability (ISS) by GCC.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2014, Bioanalysis.

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

Roger Hayes, Jennifer Zimmer, Xinping Fang, 2014, Bioanalysis.

Recommendations on biomarker bioanalytical method validation by GCC.

Roger Hayes, Fabio Garofolo, John Allinson, 2012, Bioanalysis.

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Aparna Kasinath, Dominique Gouty, Xiao-Yan Cai, 2014, The AAPS Journal.

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.

Dominique Gouty, Xiao-Yan Cai, Ashleigh Wake, 2013, Bioanalysis.

Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.

Roger Hayes, Jennifer Zimmer, Xinping Fang, 2012, Bioanalysis.

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

Roger Hayes, Jennifer Zimmer, Xinping Fang, 2012, Bioanalysis.

7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2014, Bioanalysis.