Mathilde Yu

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.

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.

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 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.