R. Nicholson

发表

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Sam H Haidar, Lauren F. Stevenson, Lauren F Stevenson, 2012, Bioanalysis.

Recommendations on biomarker bioanalytical method validation by GCC.

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

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Eric Woolf, Binodh DeSilva, Lauren Stevenson, 2014, The AAPS Journal.

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.

Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

Lauren F. Stevenson, Sam H. Haidar, B. Desilva, 2015, The AAPS Journal.

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 incurred sample stability (ISS) by GCC.

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

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

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

Method Transfer, Partial Validation, and Cross Validation: Recommendations for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

K. S. Mahesh, P. Hu, F. Vazvaei, 2014, The AAPS Journal.