Corey Nehls

2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

Fabio Garofolo, Mario L. Rocci, Isabelle Dumont et al. · Bioanalysis · 2011 · 93 citations

Pharmacy, Chemistry, Pharmaceutical Analysis +15

Recommendations On: Internal Standard Criteria, Stability, Incurred Sample Reanalysis and Recent 483s by the Global CRO Council for Bioanalysis

Steve Lowes, Jim Jersey, Ronald E. Shoup et al. · Bioanalysis · 2011 · 88 citations

Pharmacy, Toxicology, Analytical Chemistry +13

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)

Eric Yang, Jan Welink, Stephanie Cape et al. · Bioanalysis · 2016 · 48 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +17

Recommendations on Incurred Sample Stability (ISS) by GCC

Steve Lowes, Richard LeLacheur, Ronald E. Shoup et al. · Bioanalysis · 2014 · 34 citations

Pharmacy, Chemistry, Analytical Chemistry +16

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( <u>Part 2</u> – Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

Brian Booth, Lauren Stevenson, Renuka Pillutla et al. · Bioanalysis · 2019 · 32 citations · Full text

Pharmacy, Biomedical Sciences, Biopharmaceutics +9