Corey Nehls

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.

2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.

Stacy Ho, Eric Woolf, Binodh DeSilva, 2011, Bioanalysis.

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

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

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

Stephanie Cape, Scott Summerfield, Amanda Wilson, 2016, 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.

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.

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

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