Mike Buonarati

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.

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.

Formation of a Global Contract Research Organization Council for Bioanalysis.

Xinping Fang, Fabio Garofolo, Chad Briscoe, 2010, Bioanalysis.

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.

Roger Hayes, Zhongping John Lin, Fabio Garofolo, 2011, Bioanalysis.

Recommendations on incurred sample stability (ISS) by GCC.

Stephanie Cape, Roger Hayes, Jennifer Zimmer, 2014, 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 on biomarker bioanalytical method validation by GCC.

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

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.