Publications by authors named "Corey Nehls"

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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( - 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, Michael Buonarati, Chris Beaver, Corey Nehls

Bioanalysis· December 2019

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Contract research organization commentary on the importance of harmonization and the impact of ICH M10.
Chad Briscoe, Corey Nehls, Mike Buonarati, Stephanie Cape, Rafiqul Islam

Bioanalysis· September 2019

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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline.
Corey Nehls, Michael Buonarati, Stephanie Cape, Rafiq Islam, Christina Satterwhite

Bioanalysis· September 2019

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12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Chad Briscoe, Nicola Hughes, Roger Hayes, Rafiq Islam, Patrick Bennett, Corey Nehls

Bioanalysis· June 2019

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Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis.
Rafiq Islam, Sumit Kar, Hanna Ritzén, Amanda Hays, Rabab Tayyem, Corey Nehls

Bioanalysis· April 2019

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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.
Rafiq Islam, Chad Briscoe, Joseph Bower, Stephanie Cape, Mark Arnold, Corey Nehls

Bioanalysis· April 2018

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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, Rafiq Islam, Corey Nehls, John Allinson, Afshin Safavi

Bioanalysis· April 2017

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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, Eric Woolf, Jens Sydor, Corey Nehls

Bioanalysis· November 2016

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7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.
Mario Rocci, Steve Lowes, Ronald Shoup, Fabio Garofolo, Raymond Farmen, Corey Nehls

Bioanalysis· October 2014

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Recommendations on incurred sample stability (ISS) by GCC.
Steve Lowes, Richard LeLacheur, Ronald Shoup, Fabio Garofolo, Isabelle Dumont, Corey Nehls

Bioanalysis· September 2014

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2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections.
Fabio Garofolo, Mario L Rocci, Isabelle Dumont, Suzanne Martinez, Steve Lowes, Corey Nehls

Bioanalysis· September 2011

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Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Steve Lowes, Jim Jersey, Ronald Shoup, Fabio Garofolo, Natasha Savoie, Corey Nehls

Bioanalysis· June 2011

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