Nicola Hughes

发表

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

Barry Jones, Jianing Zeng, An Song, 2016, Bioanalysis.

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.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).

Roger Hayes, Amanda Wilson, Eric Woolf, 2015, 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.

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.

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

Surinder Kaur, Jian Wang, Fabio Garofolo, 2015, 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.