D. Gouty

发表

Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development.

C. Cullen, Xiao-Yan Cai, Jeff Thomas, 2012, Bioanalysis.

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.

C. Cullen, S. Baughman, Xiao-Yan Cai, 2011, Bioanalysis.

GlycoPEGylation of recombinant therapeutic proteins produced in Escherichia coli.

R. Bayer, D. Zopf, E. B. D. Brinkman-van der Linden, 2006, Glycobiology.

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Sam H Haidar, Lauren F. Stevenson, Lauren F Stevenson, 2012, Bioanalysis.

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

Rafiq Islam, R. Lelacheur, S. Reuschel, 2012 .

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

B. Babbitt, X. Cai, D. Peritt, 2017, The AAPS Journal.

Recommendations on biomarker bioanalytical method validation by GCC.

Roger Hayes, Fabio Garofolo, John Allinson, 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.

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.

Recommendations on incurred sample stability (ISS) by GCC.

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

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.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Lindsay King, Roger Hayes, Surinder Kaur, 2014, Bioanalysis.

2 Bioanalytical report writing

Kevin Bateman, Roger Hayes, Eric Woolf, 2022 .