Corey Nehls

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).

Bioanalysis 2019 Dec 9;11(23):2099-2132. Epub 2019 Dec 9.

US FDA, Silver Spring, MD, USA.

December 2019

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

Authors:

Corey Nehls Michael Buonarati Stephanie Cape Rafiq Islam Christina Satterwhite Chad Briscoe Roger Hayes Andrew Dinan Kurt Sales Shelby Anderson Jennifer Vance John Lindsay Jennifer Zimmer Philippe Couerbe Ardeshir Khadang Sarah Maasjo Orlando Bravo Kathie Lindley Liam Moran Timothy Sangster Jenifer Vija John Stamatopoulos Jenny Lin Scott Reuschel Angie Underberg Robert MacNeill Luca Matassa Adriane Spytko Wei Garofolo Natasha Savoie Paul Rhyne Jason Ambrosius Valentine Barra Dawn Dufield Marsha Luna Franklin Spriggs Evgueni Fedorov Hanna Ritzén Saadya Fatmi Cheikh Kane Mohammed Bouhajib Chantal DiMarco Adriana Iordachescu Ariana Tudoroniu Esme Farley Bruce Stouffer Edward Tabler Stacie McCown Joseph Bower Travis Harrison Shane Karnik Michael Brown Philip Joyce Ira DuBey Brian Hoffpauir Nadine Boudreau Jerome Bergeron Hao Wang Hao Feng Shaolian Zhou Edward Wells John Pirro Xinping Fang Jing Shi Changming Yang

Bioanalysis 2019 Sep 30;11(18s):1-228. Epub 2019 Sep 30.

WuXi Apptec, Shanghai, China.

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September 2019

Contract research organization commentary on the importance of harmonization and the impact of ICH M10.

Authors:

Chad Briscoe Corey Nehls Mike Buonarati Stephanie Cape Rafiqul Islam Christina Satterwhite Roger Hayes

Bioanalysis 2019 Sep 26;11(18):1727-1729. Epub 2019 Sep 26.

ICON plc, Whitesboro, NY 13492, USA.

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September 2019

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

Authors:

Chad Briscoe Nicola Hughes Roger Hayes Rafiq Islam Patrick Bennett Bruce Stouffer Stephanie Cape Paul Rhyne Chris Beaver Jessica St Charles Vellalore Kakkanaiah Allan Xu Maria Cruz Caturla Franklin Spriggs Rabab Tayyem Colin Barry Anahita Keyhani Jennifer Zimmer Philippe Couerbe Mark Warren Ardeshir Khadang James Bourdage Kathie Lindley Dave Williams Curtis Sheldon Christina Satterwhite Jenifer Vija Mathilde Yu Iohann Boulay John Stamatopoulos Jenny Lin Sian Estdale Eric Thomas Andrew Dinan Robert MacNeill Yi Qun Xiao Luca Matassa Wei Garofolo Natasha Savoie George Hristopoulos Arron Xu Lawrence Goodwin Kayode Awaiye Hanna Ritzén Mohammed Bouhajib Chantal Di Marco Simona Rizea Savu Corey Nehls Edward Tabler Amanda Hays Shane Karnik Michael Brown Steve Lowes Ira DuBey Nadia Kulagina John Lindsay Clark Williard Hao Wang Michele Malone Edward Wells Xinping Fang Marc Moussallie

Bioanalysis 2019 Jun 19;11(12):1129-1138. Epub 2019 Jul 19.

WuXi Apptec, Plainsboro, NJ 08536, USA.

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June 2019

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

Authors:

Rafiq Islam Sumit Kar Hanna Ritzén Amanda Hays Rabab Tayyem Colin Barry Anahita Keyhani Jennifer Zimmer Maria Cruz Caturla Philippe Couerbe Mark Warren Ardeshir Khadang James Bourdage Kathie Lindley Dave Williams Nicola Hughes Curtis Sheldon Christina Satterwhite Jenifer Vija Mathilde Yu Iohann Boulay John Stamatopoulos Jenny Lin Stephanie Cape Sian Estdale Eric Thomas Andrew Dinan Robert MacNeill Yi Qun Xiao Wei Garofolo Natasha Savoie Michael Brown Paul Rhyne George Hristopoulos Arron Xu Lawrence Goodwin Franklin Spriggs Allan Xu Kayode Awaiye Roger Hayes Jessica St Charles Mohammed Bouhajib Chantal DiMarco Luigi DiMarco Simona Rizea Savu Patrick Bennett Vellalore Kakkanaiah Corey Nehls Bruce Stouffer Edward Tabler Chad Briscoe Shane Karnik Ira DuBey Nadia Kulagina John Lindsay Chris Beaver Clark Williard Hao Wang Hao Feng Michele Malone Edward Wells Xinping Fang Marc Moussallie

Bioanalysis 2019 Apr 17;11(7):645-653. Epub 2019 Apr 17.

WuXi Apptec, Plainsboro, NJ, USA.

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April 2019

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.

Authors:

Rafiq Islam Chad Briscoe Joseph Bower Stephanie Cape Mark Arnold Roger Hayes Mark Warren Shane Karnik Bruce Stouffer Yi Qun Xiao Barry van der Strate Daniel Sikkema Xinping Fang Ariana Tudoroniu Rabab Tayyem Ashley Brant Franklin Spriggs Colin Barry Masood Khan Anahita Keyhani Jennifer Zimmer Maria Cruz Caturla Philippe Couerbe Ardeshir Khadang James Bourdage Jim Datin Jennifer Zemo Nicola Hughes Saadya Fatmi Curtis Sheldon Scott Fountain Christina Satterwhite Kelly Colletti Jenifer Vija Mathilde Yu John Stamatopoulos Jenny Lin Jim Wilfahrt Andrew Dinan Susan Ohorodnik James Hulse Vimal Patel Wei Garofolo Natasha Savoie Michael Brown Damon Papac Mike Buonarati George Hristopoulos Chris Beaver Nadine Boudreau Clark Williard Yansheng Liu Gene Ray Dominic Warrino Allan Xu Rachel Green Joanne Hayward-Sewell John Marcelletti Christina Sanchez Michael Kennedy Jessica St Charles Mohammed Bouhajib Corey Nehls Edward Tabler Jing Tu Philip Joyce Adriana Iordachescu Ira DuBey John Lindsay Jim Yamashita Edward Wells

Bioanalysis 2018 Apr 27;10(7):433-444. Epub 2018 Apr 27.

Worldwide Clinical Trials, Austin, TX, USA.

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April 2018

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.

Authors:

Stephanie Cape Rafiq Islam Corey Nehls John Allinson Afshin Safavi Patrick Bennett James Hulse Chris Beaver Masood Khan Shane Karnik Maria Cruz Caturla Steve Lowes Adriana Iordachescu Luigi Silvestro Rabab Tayyem Ron Shoup Stephanie Mowery Anahita Keyhani Andrea Wakefield Yinghe Li Jennifer Zimmer Javier Torres Philippe Couerbe Ardeshir Khadang James Bourdage Nicola Hughes Kayode Awaiye Brent Matthews Saadya Fatmi Rhonda Johnson Christina Satterwhite Mathilde Yu Jenny Lin Laura Cojocaru Michele Fiscella Eric Thomas Kai Kurylak John Kamerud Zhongping John Lin Wei Garofolo Natasha Savoie Mike Buonarati Nadine Boudreau Clark Williard Yansheng Liu Dominic Warrino Prashant Kale Neil Adcock Radha Shekar Edward O'Connor Hanna Ritzen Christina Sanchez Roger Hayes Mohammed Bouhajib Simona Rizea Savu Bruce Stouffer Edward Tabler Jing Tu Chad Briscoe Barry van der Strate Paul Rhyne Phyllis Conliffe Ira DuBey Jim Yamashita Daniel Tang Elizabeth Groeber Jenifer Vija Michele Malone Mohamed Osman

Bioanalysis 2017 Apr 24;9(7):505-516. Epub 2017 Mar 24.

WuXi Apptec, Plainsboro, NJ, USA.

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April 2017

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).

Bioanalysis 2016 Nov 7;8(22):2363-2378. Epub 2016 Oct 7.

Novartis, Emeryville, CA, USA.

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November 2016

7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing.

Bioanalysis 2014 Oct;6(20):2713-20

ICON Laboratories, Whitesboro, NY, USA.

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October 2014

Recommendations on incurred sample stability (ISS) by GCC.

Bioanalysis 2014 Sep;6(18):2385-90

Quintiles Bioanalytical & ADME Labs, Ithaca, NY, USA.

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September 2014

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

Bioanalysis 2011 Sep;3(18):2081-96

Algorithme Pharma Inc., Laval (Montreal) Quebec, H7V 4B3, Canada.

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September 2011

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.

Bioanalysis 2011 Jun;3(12):1323-32

Advion BioServices, Ithaca, NY, USA.

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June 2011

Publications by authors named "Corey Nehls"

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