Philippe Couerbe

发表

The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2017, Bioanalysis.

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.

Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum.

Fabio Garofolo, Rachel Green, Jaap Wieling, 2011, Bioanalysis.

4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

Roger Hayes, Xinping Fang, Fabio Garofolo, 2012, 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 on incurred sample stability (ISS) by GCC.

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

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

Roger Hayes, Xinping Fang, Zhongping John Lin, 2012, Bioanalysis.

Recommendations on biomarker bioanalytical method validation by GCC.

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

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2016, 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.

Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).

Fabio Garofolo, Rachel Green, Colin Pattison, 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.