Publications by authors named "John Kamerud"

22 Publications

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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).

Authors:
Bart Corsaro Tong-Yuan Yang Rocio Murphy Ivo Sonderegger Andrew Exley Sylvie Bertholet Naveen Dakappagari Francis Dessy Fabio Garofolo Lisa Kierstead Holger Koch Ghanashyam Sarikonda Natasha Savoie Richard Siggers Therese Solstad Yanmei Lu Mark Milton Jean-Claude Marshall Jason DelCarpini Boris Gorovits Swati Gupta Lynne Jesaitis John Kamerud Arno Kromminga Anna Ma Jim McNally Haoheng Yan Bonnie Wu Daniela Verthelyi Susan Kirshner Joao Pedras-Vasconcelos Manoj Rajadhyaksha Roland F Staack Elana Cherry Isabelle Cludts Madeleine Dahlbäck George R Gunn Akiko Ishii-Watabe Vibha Jawa Robert Kubiak Michael Partridge Marco Petrillo Samuel O Pine Johann Poetzl Sam Song Chris Stebbins Yuling Wu Lucia Zhang Sumit Kar Meina Liang Mohsen Rajabi Abhari Becky Schweighardt Kay Stubenrauch Yuanxin Xu

Bioanalysis 2021 Feb 3. Epub 2021 Feb 3.

Intellia Therapeutics, Cambridge, MA, USA.

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February 2021

Strategies to develop highly drug-tolerant cell-based neutralizing antibody assay: neutralizing antidrug antibodies extraction and drug depletion.

Authors:
Zhihua Jiang John Kamerud Minlei Zhang Carlos Cabrera Ruiz Crisanto Guadiz Alexander Fichtner Boris Gorovits

Bioanalysis 2020 Sep 18;12(18):1279-1293. Epub 2020 Sep 18.

BioMedicine Design, Pfizer Inc. Andover, MA 01810, USA.

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September 2020

Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population.

Authors:
Charles Y Tan Gregory S Steeno Zhiping You Puneet Gaitonde Chun-Hua Cai John Kamerud Boris Gorovits Daniel J Baltrukonis

AAPS J 2020 01 3;22(2):19. Epub 2020 Jan 3.

Worldwide Research Development and Medical, Pfizer Inc., 500 Arcola Rd, Collegeville, Pennsylvania, 19426, USA.

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January 2020

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).

Authors:
Brian Booth Lauren Stevenson Renuka Pillutla Michael Buonarati Chris Beaver Daniela Fraier Fabio Garofolo Sam Haidar Rafiq Islam Christopher James John Kadavil Olga Kavetska Fumin Li Christina Satterwhite Natasha Savoie Sriram Subramaniam Nilufer Tampal Theingi Thway Eric Woolf Olivier Le Blaye Matthew Andisik Chad Briscoe Stephanie Cape Arindam Dasgupta Sally Fischer Sam Haidar Roger Hayes John Kamerud Gustavo Mendes Lima Santos Corey Nehls Catherine Soo Stephen Vinter Emma Whale Keyang Xu Seongeun Julia Cho Anna Edmison Sean Kassim Thais Correa Rocha Jan Welink Shashi Amur Abbas Bandukwala Elana Cherry Shirley Hopper Akiko Ishii-Watabe Susan Kirshner Kevin Maher Joao Pedras-Vasconcelos Yoshiro Saito Therese Solstad Saunders Venke Skibeli Daniela Verthelyi Yow-Ming Wang Haoheng Yan

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

US FDA, Silver Spring, MD, USA.

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December 2019

Anti-drug Antibody Assay Validation: Improved Reporting of the Assay Selectivity via Simpler Positive Control Recovery Data Analysis.

Authors:
Boris Gorovits Marcela Araya Roldan Daniel Baltrukonis Chun-Hua Cai Jean Donley Darshana Jani John Kamerud Frederick McCush Jeffrey S Thomas Ying Wang

AAPS J 2019 06 18;21(5):76. Epub 2019 Jun 18.

Pfizer Inc., 1 Burtt Rd., Andover, MA, 01810, USA.

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June 2019

Anti-drug Antibody Assay Conditions Significantly Impact Assay Screen and Confirmatory Cut-Points.

Authors:
Boris Gorovits Ying Wang Liang Zhu Marcela Araya John Kamerud Christopher Lepsy

AAPS J 2019 06 3;21(4):71. Epub 2019 Jun 3.

Pfizer Inc., 1 Burtt Rd, Andover, Massachusetts, 01810, USA.

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June 2019

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).

Authors:
Lauren Stevenson Susan Richards Renuka Pillutla Albert Torri John Kamerud Devangi Mehta Stephen Keller Shobha Purushothama Boris Gorovits Virginia Litwin Christopher Stebbins Joseph Marini Chris Beaver Gizette Sperinde Patricia Siguenza Roland F Staack Yongchang Qiu Lakshmi Amaravadi Shashi Amur Catherine Aversa Fleener Daniel Baltrukonis Ian Catlett Elana Cherry Shan Chung Isabelle Cludts Lorella Di Donato Saloumeh Fischer Stephanie Fraser Fabio Garofolo Cherie Green George Gunn Sam Haidar Jonathan Haulenbeek Neil Henderson Shirley Hopper Akiko Ishii-Watabe Rafiq Islam Brian Janelsins Vibha Jawa Vellalore Kakkanaiah Szilard Kamondi Gerry Kolaitis Robert J Kubiak Seema Kumar Pekka Kurki Meina Liang Patrick Liu Kimberly Maxfield Heather Myler Nisha Palackal Rachel Palmer João Pedras-Vasconcelos Steven Piccoli Paul Rhyne Yoshiro Saito Natasha Savoie Eginhard Schick Becky Schweighardt Judy Shih An Song Priya Sriraman Ludovicus Staelens Giane Sumner Yongliang Sun Martin Ullmann Daniela Verthelyi Meenu Wadhwa Yow-Ming Wang Yuanxin Xu Haoheng Yan Tong-Yuan Yang Rong Zeng

Bioanalysis 2018 Dec 29;10(24):1973-2001. Epub 2018 Nov 29.

Amador Bioscience, Pleasanton, CA, USA (formerly of OncoMed, Redwood City, CA, USA).

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December 2018

Approaches to Resolve False Reporting in Neutralizing Antibody Assays Caused by Reagent Leaching from Affinity Capture Elution Solid Phase.

Authors:
Yuhong Xiang John Kamerud Jean Donley Katrina Olson Teresa Caiazzo Dave Yeung Chuenlei Parng Boris Gorovits

AAPS J 2018 11 6;21(1). Epub 2018 Nov 6.

Pfizer Worldwide Research & Development, Biomedicine Design, 1 Burtt Rd., Andover, Massachusetts, 01810, USA.

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November 2018

A Simple Approach to Determine a Curve Fitting Model with a Correct Weighting Function for Calibration Curves in Quantitative Ligand Binding Assays.

Authors:
Yuhong Xiang Jean Donley Elena Seletskaia Sonal Shingare John Kamerud Boris Gorovits

AAPS J 2018 03 13;20(3):45. Epub 2018 Mar 13.

Pfizer Worldwide Research & Development, Biomedicine Design, 1 Burtt Rd, Andover, Massachusetts, 01810, USA.

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March 2018

Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves.

Authors:
Mitra Azadeh Boris Gorovits John Kamerud Stephen MacMannis Afshin Safavi Jeffrey Sailstad Perceval Sondag

AAPS J 2017 12 27;20(1):22. Epub 2017 Dec 27.

Arlenda Inc., Flemington, NJ, USA.

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December 2017

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).

Authors:
Shalini Gupta Susan Richards Lakshmi Amaravadi Steven Piccoli Binodh Desilva Renuka Pillutla Lauren Stevenson Devangi Mehta Montserrat Carrasco-Triguero Robert Neely Michael Partridge Roland F Staack Xuemei Zhao Boris Gorovits Gerry Kolaitis Giane Sumner Kay-Gunnar Stubenrauch Linglong Zou Shashi Amur Chris Beaver Isabella Berger Flora Berisha Herbert Birnboeck Joe Bower Seongeun Julia Cho Isabelle Cludts Laurent Cocea Lorella Di Donato Saloumeh Fischer Stephanie Fraser Fabio Garofolo Sam Haidar Jonathan Haulenbeek Charles Hottenstein Jenny Hu Akiko Ishii-Watabe Rafiq Islam Darshana Jani John Kadavil John Kamerud Daniel Kramer Pekka Kurki Stephen MacMannis Jim McNally Ashley Mullan Apollon Papadimitriou João Pedras-Vasconcelos Soma Ray Afshin Safavi Yoshiro Saito Natasha Savoie Marianne Scheel Fjording Kara Scheibner John Smeraglia An Song Bruce Stouffer Nilufer Tampal Barry van der Strate Thorsten Verch Jan Welink Yuanxin Xu Tong-Yuan Yang Lilian Yengi Jianing Zeng Yan Zhang Yanhua Zhang Stephen Zoog

Bioanalysis 2017 Dec 5;9(24):1967-1996. Epub 2017 Dec 5.

BioMarin Pharmaceutical, San Rafael, CA, USA.

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December 2017

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 3 - LBA, biomarkers and immunogenicity).

Authors:
Susan Richards Lakshmi Amaravadi Renuka Pillutla Herbert Birnboeck Albert Torri Kyra J Cowan Apollon Papadimitriou Fabio Garofolo Christina Satterwhite Steven Piccoli Bonnie Wu Corinna Krinos-Fiorotti John Allinson Flora Berisha Laurent Cocea Stephanie Croft Stephanie Fraser Fabrizio Galliccia Boris Gorovits Swati Gupta Vinita Gupta Sam Haidar Charles Hottenstein Akiko Ishii-Watabe Darshana Jani John Kadavil John Kamerud Daniel Kramer Virginia Litwin Gustavo Mendes Lima Santos Robert Nelson Yan Ni João Pedras-Vasconcelos Yongchang Qiu Paul Rhyne Afshin Safavi Yoshiro Saito Natasha Savoie Kara Scheibner Eginhard Schick Patricia Y Siguenza John Smeraglia Roland F Staack Meena Subramanyam Giane Sumner Theingi Thway David Uhlinger Martin Ullmann Alessandra Vitaliti Jan Welink Chan C Whiting Li Xue Rong Zeng

Bioanalysis 2016 Dec;8(23):2475-2496

OncoMed Pharmaceuticals, Redwood City, CA, USA.

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December 2016

2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).

Authors:
Lakshmi Amaravadi An Song Heather Myler Theingi Thway Susan Kirshner Viswanath Devanarayan Yan G Ni Fabio Garofolo Herbert Birnboeck Susan Richards Shalini Gupta Linlin Luo Clare Kingsley Laura Salazar-Fontana Stephanie Fraser Boris Gorovits John Allinson Troy Barger Shannon Chilewski Marianne Scheel Fjording Sam Haidar Rafiqul Islam Birgit Jaitner John Kamerud Noriko Katori Corinna Krinos-Fiorotti David Lanham Mark Ma Jim McNally Alyssa Morimoto Daniel Mytych Andre Nogueira da Costa Apollon Papadimitriou Renuka Pillutla Soma Ray Afshin Safavi Natasha Savoie Martin Schaefer Judy Shih John Smeraglia Michael F Skelly Jeffrey Spond Roland F Staack Bruce Stouffer Nilufer Tampal Albert Torri Jan Welink Tong-Yuan Yang Jad Zoghbi

Bioanalysis 2015 Dec 4;7(24):3107-24. Epub 2015 Dec 4.

Sanofi, Framingham, MA, USA.

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December 2015

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

Authors:
Joseph Bower Douglas Fast Fabio Garofolo Dominique Gouty Roger Hayes Steve Lowes Robert Nicholson Richard LeLacheur Jennifer Bravo Ronald Shoup Isabelle Dumont Mary Carbone Jennifer Zimmer Jordi Ortuno Maria Cruz Caturla Jim Datin Tim Lansing Saadya Fatmi Petra Struwe Curtis Sheldon Rafiqul Islam Mathilde Yu Jim Hulse John Kamerud John Lin John Doughty Kai Kurylak Daniel Tang Mike Buonarati Alexandre Blanchette Ann Levesque Sofi Gagnon-Carignan Jenny Lin Gene Ray Yanseng Liu Masood Khan Allan Xu Gibran El-Sulayman Chantal DiMarco Mohammed Bouhajib Dick Tacey Rand Jenkins Barry van der Strate Chad Briscoe Shane Karnik Paul Rhyne Wei Garofolo Gary Schultz Andrew Roberts Mike Redrup Ira DuBey Phyllis Conliffe Teri Pekol Jamil Hantash Laura Cojocaru Mike Allen Scott Reuschel Andrea Watson Colin Farrell Elizabeth Groeber Michele Malone William Nowatzke Xinping Fang

Bioanalysis 2014 ;6(22):2957-63

Covance Laboratories, Chantilly, VA, USA.

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July 2015

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

Authors:
Mario Rocci Steve Lowes Ronald Shoup Fabio Garofolo Raymond Farmen Tianyi Zhang John Allinson Dominique Gouty Roger Hayes Robert Nicholson Richard Houghton Isabelle Dumont Richard LeLacheur Jennifer Zimmer Maria Cruz Caturla Philippe Couerbe Kayode Awaiye Saadya Fatmi Curtis Sheldon Joseph Bower Michelle Fiscella Douglas Fast Stephanie Cape Jim Hulse John Kamerud Stephanie Pasas-Farmer Wei Garofolo Marc Moussallie Mike Buonarati Nadine Boudreau Brigitte Pellerin Jenny Lin Allan Xu Mohammed Bouhajib Mary Stipancic Corey Nehls Mark Warren Shane Karnik Craig Stovold Scott Reuschel Laura Cojocaru John Marcelletti Xinping Fang Ian Smith Andrea Watson

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.

Authors:
Steve Lowes Richard LeLacheur Ronald Shoup Fabio Garofolo Isabelle Dumont Suzanne Martinez Jennifer Zimmer Maria Cruz Caturla Philippe Couerbe Kayode Awaiye Saadya Fatmi Raymond Farmen Curtis Sheldon Joseph Bower Michele Fiscella Douglas Fast Stephanie Cape Jim Hulse John Kamerud Tee Zhang Stephanie Pasas-Farmer Wei Garofolo Marc Moussallie Mario Rocci John Allinson Dominique Gouty Mike Buonarati Nadine Boudreau Brigitte Pellerin Jenny Lin Allan Xu Roger Hayes Mohammed Bouhajib Mary Stipancic Robert Nicholson Corey Nehls Mark Warren Shane Karnik Richard Houghton Craig Stovold Scott Reuschel Laura Cojocaru John Marcelletti Xinping Fang Ian Smith Andrea Watson

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

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

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September 2014

Theoretical considerations and practical approaches to address the effect of anti-drug antibody (ADA) on quantification of biotherapeutics in circulation.

Authors:
Marian Kelley Ago B Ahene Boris Gorovits John Kamerud Lindsay E King Thomas McIntosh Jihong Yang

AAPS J 2013 Jul 30;15(3):646-58. Epub 2013 Mar 30.

MKelley Consulting LLC, 1533 Glenmont Lane, West Chester, PA 19380, USA.

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July 2013

Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.

Authors:
Robert Nicholson Steve Lowes Maria Cruz Caturla Afshin Safavi Dan Mamelak Rafiq Islam John Allinson Dominique Gouty Masood Khan Richard Lelacheur Ronald Shoup Suzanne Martinez Isabelle Dumont Jennifer Zimmer Ray Steffen James Petrilla Kayode Awaiye Curtis Sheldon Douglas Turk Douglas Fast John Kamerud Andrew Dinan Zhongping John Lin Wei Garofolo Daniel Tang Laura Wright Jenny Lin Yasuhiro Yamashita Yansheng Liu Allan Xu Roger Hayes Mohammed Bouhajib Ann Levesque Sofi Gagnon-Carignan Jake Harman Mark Warren Shane Karnik Laura Cojocaru Scott Reuschel Pilar Gonzalez Saadya Fatmi Jenifer Vija Marie Rock Michele Malone William Nowatzke Xinping Fang

Bioanalysis 2012 Oct;4(19):2335-42

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October 2012

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Authors:
Steve Lowes Mark Boterman Mira Doig Massimo Breda Jim Jersey Richard Lelacheur Ronald Shoup Fabio Garofolo Isabelle Dumont Suzanne Martinez Shane Needham Jennifer Zimmer Maria Cruz Caturla Philippe Couerbe John Maltas Ray Steffen James Petrilla Afshin Safavi Kayode Awaiye Masood Bhatti Curtis Sheldon Christine Schiebl Petra Struwe Douglas Turk Timothy Sangster Colin Pattison Douglas Fast Lee Goodwin John Kamerud Andrew Dinan Dan Mamelak Rafiq Islam Rudi Segers Zhongping John Lin Jim Hillier Wei Garofolo Lois Folguera Dieter Zimmer Thomas Zimmermann Maria Pawula Marc Moussallie Leonardo de Souza Teixeira Thais Rocha John Allinson Paula Jardieu Daniel Tang Dominique Gouty Laura Wright James Truog Jenny Lin Yasuhiro Yamashita Masood Khan Yansheng Liu Allan Xu Richard Lundberg Chris Cox Alan Breau Roger Hayes Chiara Bigogno Dick Schoutsen Carmen Dilger Jianine Jonker Mohammed Bouhajib Ann Levesque Sofi Gagnon-Carignan Jake Harman Robert Nicholson Rand Jenkins Mark Warren Ming Hung Lin Shane Karnik Theo De Boer Richard Houghton Rachel Green William Demaio Romuald Sable Kirk Smith Christoph Siethoff Laura Cojocaru Mike Allen Scott Reuschel Pilar Gonzalez Tammy Harter Saadya Fatmi Marie Rock Jenifer Vija Farhad Sayyarpour Michele Malone William Nowatzke Stuart Best Xinping Fang

Bioanalysis 2012 Sep;4(17):2117-26

Advion Bioanalytical Laboratories, Quintiles, NY, USA.

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September 2012

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

Authors:
Steve Lowes Jim Jersey Ronald Shoup Fabio Garofolo Natasha Savoie Ejvind Mortz Shane Needham Maria Cruz Caturla Ray Steffen Curtis Sheldon Roger Hayes Tim Samuels Lorella Di Donato John Kamerud Steve Michael Zhongping John Lin Jim Hillier Marc Moussallie Leonardo de Souza Teixeira Mario Rocci Mike Buonarati James Truog Saleh Hussain Richard Lundberg Alan Breau Tianyi Zhang Jianine Jonker Neil Berger Sofi Gagnon-Carignan Corey Nehls Robert Nicholson Martijn Hilhorst Shane Karnik Theo de Boer Richard Houghton Kirk Smith Laura Cojocaru Mike Allen Tammy Harter Saadya Fatmi Farhad Sayyarpour Jenifer Vija Michele Malone Dennis Heller

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

Advion BioServices, Ithaca, NY, USA.

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June 2011

Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development.

Authors:
Jean W Lee Marian Kelley Lindsay E King Jihong Yang Hossein Salimi-Moosavi Meina T Tang Jian-Feng Lu John Kamerud Ago Ahene Heather Myler Cindy Rogers

AAPS J 2011 Mar 15;13(1):99-110. Epub 2011 Jan 15.

Amgen Inc, One Amgen Center Drive, Thousand Oaks, California 91320, USA.

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March 2011