Publications by authors named "Hanna Ritzen"

5 Publications

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

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

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

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.

Authors:

Roger Hayes Richard LeLacheur Isabelle Dumont Philippe Couerbe Afshin Safavi Rafiq Islam Colin Pattison Stephanie Cape Mario Rocci Chad Briscoe Laura Cojocaru Elizabeth Groeber Luigi Silvestro Jennifer Bravo Ron Shoup Manon Verville Jennifer Zimmer Maria Cruz Caturla Ardeshir Khadang James Bourdage Nicola Hughes Saadya Fatmi Lorella Di Donato Curtis Sheldon Anahita Keyhani Christina Satterwhite Mathilde Yu Michele Fiscella James Hulse Zhongping John Lin Wei Garofolo Natasha Savoie Yi Qun Xiao Kai Kurylak Sarah Harris Manju Saxena Mike Buonarati Ann Lévesque Nadine Boudreau Jenny Lin Masood U Khan Gene Ray Yansheng Liu Allan Xu Gunjan Soni Ian Ward Clare Kingsley Hanna Ritzén Edward Tabler Bob Nicholson Patrick Bennett Nico van de Merbel Shane Karnik Mohammed Bouhajib Jaap Wieling Daniel Mulvana Benno Ingelse Mike Allen Michele Malone Xinping Fang

Bioanalysis 2016 Mar 26;8(6):487-95. Epub 2016 Feb 26.

WuXi/XBL, 107 Morgan Lane, Plainsboro, NJ, USA.

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March 2016

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