Author

Dominique Gouty

Observed name: D. Gouty

Observed institution: Intertek (United States)

OpenAlex ID: A5087919454

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

2012 · Binodh DeSilva, Fabio Garofolo, et al. · Bioanalysis · 102

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

2011 · Fabio Garofolo, Mario L Rocci, et al. · Bioanalysis · 94

2013 White Paper on Recent Issues in Bioanalysis: ‘ Hybrid ’ – The Best of LBA and LCMS

2013 · Lauren Stevenson, Fabio Garofolo, et al. · Bioanalysis · 77

Recommendations on Biomarker Bioanalytical Method Validation By Gcc

2012 · Richard Hougton, Dominique Gouty, et al. · Bioanalysis · 62

2014 White Paper on Recent Issues in Bioanalysis: A Full Immersion in Bioanalysis (Part 3 – LBA and Immunogenicity)

2014 · Lauren Stevenson, Lakshmi Amaravadi, et al. · Bioanalysis · 44

Challenges of Developing And Validating Immunogenicity Assays to Support Comparability Studies For Biosimilar Drug Development

2012 · Xiao-Yan Cai, Jeff Thomas, et al. · Bioanalysis · 38

Formation of a Global Contract Research Organization Council for Bioanalysis

2010 · Noel Premkumar, Stephen Lowes, et al. · Bioanalysis · 36

Recommendations on Incurred Sample Stability (ISS) by GCC

2014 · Steve Lowes, Richard LeLacheur, et al. · Bioanalysis · 35

Analytical and Bioanalytical Assay Challenges to Support Comparability Studies for Biosimilar Drug Development

2013 · Xiao-Yan Cai, Ashleigh Wake, et al. · Bioanalysis · 35

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

2012 · Steve Lowes, Mark Boterman, et al. · Bioanalysis · 33

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

2014 · Joseph Bower, Douglas Fast, et al. · Bioanalysis · 31

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

2014 · Joseph C. Marini, Michael Anderson, et al. · The AAPS Journal · 31

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

2012 · Robert Nicholson, Steve Lowes, et al. · Bioanalysis · 28

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

2014 · Mario Rocci, Steve Lowes, et al. · Bioanalysis · 20

Recommendations and Requirements for The Design of Bioanalytical Testing Used in Comparability Studies for Biosimilar Drug Development

2011 · Xiao-Yan Cai, Dominique Gouty, et al. · Bioanalysis · 17

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

2017 · D. Gouty, C. C. Cai, et al. · The AAPS Journal · 13

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Correction to: Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment

2018 · D. Gouty, C. C. Cai, et al. · The AAPS Journal · 2

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Erratum to: 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

2017 · Joseph C. Marini, Michael Anderson, et al. · The AAPS Journal

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White Pa P er SP ecial Focu S iSS ue: Bioanaly S i S o F B iomarker S

2012 · Richard Hougton, Dominique Gouty, et al.

Design of bioanalytical testing used in comparability studies for Biosimilars

2011 · Dominique Gouty · Journal of Bioanalysis & Biomedicine

Works count: 20

Citation count: 698

H-index: 15

I10-index: 16