Andrew Dinan

GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.

Hao Feng, Stephanie Cape, Roger Hayes, 2019, Bioanalysis.

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2018, Bioanalysis.

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

Stephanie Cape, Roger Hayes, Dave Williams, 2019, Bioanalysis.

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.

Stephanie Cape, Roger Hayes, Sumit Kar, 2019, 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.