Publications by authors named "Laura Cojocaru"

24 Publications

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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.

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

A highly sensitive and selective LC-MS/MS method to quantify asunaprevir, an HCV NS3 protease inhibitor, in human plasma in support of pharmacokinetic studies.

Authors:
Hamza Kandoussi Hao Jiang Jianing Zeng Naiyu Zheng Pathanjali Kadiyala Timothy Eley Bing He Tushar Garimella Roger Demers Laura Cojocaru Anne-Françoise Aubry Mark E Arnold

J Pharm Biomed Anal 2016 Feb 23;119:145-51. Epub 2015 Nov 23.

Analytical & Bioanalytical Development, Bristol-Myers Squibb Company, Princeton, NJ 08543, USA.

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February 2016

Multiplexed LC-MS/MS method for the simultaneous quantitation of three novel hepatitis C antivirals, daclatasvir, asunaprevir, and beclabuvir in human plasma.

Authors:
Hao Jiang Hamza Kandoussi Jianing Zeng Jian Wang Roger Demers Timothy Eley Bing He Richard Burrell John Easter Pathanjali Kadiyala Janice Pursley Laura Cojocaru Chanda Baker John Ryan Anne-Françoise Aubry Mark E Arnold

J Pharm Biomed Anal 2015 Mar 20;107:409-18. Epub 2015 Jan 20.

Analytical and Bioanalytical Development, Bristol-Myers Squibb Co., Princeton, NJ 08540, United States.

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March 2015

Sensitive and accurate liquid chromatography-tandem mass spectrometry methods for quantitative determination of a novel hepatitis C NS5B inhibitor BMS-791325 and its active metabolite in human plasma and urine.

Authors:
Hao Jiang Roger Demers Hamza Kandoussi Richard Burrell Timothy Eley Pathanjali Kadiyala Laura Cojocaru Chanda Baker John Ryan Anne-Françoise Aubry Mark E Arnold Jianing Zeng

J Pharm Biomed Anal 2015 Mar 17;107:17-23. Epub 2014 Dec 17.

Bioanalytical Sciences, Bristol-Myers Squibb Co., Princeton, NJ, United States. Electronic address:

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March 2015

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Authors:
Lauren Stevenson Lakshmi Amaravadi Heather Myler Laura Salazar-Fontana Boris Gorovits Susan Kirshner Li Xue Fabio Garofolo Stephen C Alley Theingi Thway Alison Joyce Surendra Bansal Chris Beaver Annik Bergeron Xiao-Yan Cai Laura Cojocaru Binodh DeSilva Isabelle Dumont Eric Fluhler Stephanie Fraser Dominique Gouty Swati Gupta Sam Haidar Roger Hayes Benno Ingelse Akiko Ishii-Watabe Surinder Kaur Lindsay King Omar Laterza Sheldon Leung Ann Lévesque Mark Ma Corinne Petit-Frere Renuka Pillutla Mark Rose Gary Schultz John Smeraglia Steven Swanson Albert Torri Faye Vazvaei Jason Wakelin-Smith Amanda Wilson Eric Woolf Tong-Yuan Yang

Bioanalysis 2014 ;6(24):3355-68

Biogen Idec Inc., Cambridge, MA, USA.

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August 2015

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Authors:
Dawn Dufield Hendrik Neubert Fabio Garofolo Leo Kirkovsky Lauren Stevenson Isabelle Dumont Surinder Kaur Keyang Xu Stephen C Alley Matthew Szapacs Mark Arnold Surendra Bansal Sam Haidar Jan Welink Olivier Le Blaye Jason Wakelin-Smith Emma Whale Akiko Ishii-Watabe Mark Bustard Noriko Katori Lakshmi Amaravadi Anne-Françoise Aubry Chris Beaver Annik Bergeron Xiao-Yan Cai Laura Cojocaru Binodh DeSilva Jeff Duggan Eric Fluhler Boris Gorovits Swati Gupta Roger Hayes Stacy Ho Benno Ingelse Lindsay King Ann Lévesque Steve Lowes Mark Ma Adrien Musuku Heather Myler Timothy Olah Shefali Patel Mark Rose Gary Schultz John Smeraglia Steven Swanson Albert Torri Faye Vazvaei Amanda Wilson Eric Woolf Li Xue Tong-Yuan Yang

Bioanalysis 2014 ;6(23):3237-49

Pfizer, Andover, MA, USA.

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August 2015

Quantitative determination of free/bound atazanavir via high-throughput equilibrium dialysis and LC-MS/MS, and the application in ex vivo samples.

Authors:
Xiaohui Sophia Xu Anne Rose Roger Demers Timothy Eley John Ryan Bruce Stouffer Laura Cojocaru Mark Arnold

Bioanalysis 2014 ;6(23):3169-82

R&D, Bristol-Myers Squibb, Mail Stop J22-06, PO Box 4000, Princeton, NJ 08543, USA.

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August 2015

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

Authors:
Eric Fluhler Roger Hayes Fabio Garofolo Isabelle Dumont Olivier Le Blaye Mark Arnold Surendra Bansal Tom Verhaeghe Amanda Wilson Lauren Stevenson Heather Myler Ronald Bauer Annik Bergeron Mark Bustard Xiao-Yan Cai Mary Carbone Laura Cojocaru Daksha Desai-Krieger Jeff Duggan Sam Haidar Stacy Ho Benno Ingelse Noriko Katori Ann Lévesque Steve Lowes Mark Ma Katalina Mettke Josée Michon Adrien Musuku Timothy Olah Shefali Patel Mark Rose Gary Schultz John Smeraglia Neil Spooner Bruce Stouffer Faye Vazvaei Jason Wakelin-Smith Jian Wang Jan Welink Emma Whale Eric Woolf Li Xue Tong-Yuan Yang

Bioanalysis 2014 ;6(22):3039-49

Pfizer, Pearl River, NY, USA.

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July 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 for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.

Authors:
Rand Jenkins Jeffrey X Duggan Anne-Françoise Aubry Jianing Zeng Jean W Lee Laura Cojocaru Dawn Dufield Fabio Garofolo Surinder Kaur Gary A Schultz Keyang Xu Ziping Yang John Yu Yan J Zhang Faye Vazvaei

AAPS J 2015 Jan 13;17(1):1-16. Epub 2014 Nov 13.

Chromatographic Sciences, PPD Bioanalytical Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230, USA.

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January 2015

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

Primary Prevention Programme for Burnout-Endangered Teachers: Follow-Up Effectiveness of a Combined Group and Individual Intervention of AFA Breathing Therapy.

Authors:
Katja Goetz Thomas Loew Regina Hornung Laura Cojocaru Claas Lahmann Karin Tritt

Evid Based Complement Alternat Med 2013 28;2013:798260. Epub 2013 Aug 28.

Department of General Practice and Health Services Research, University Hospital of Heidelberg, 69115 Heidelberg, Germany.

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September 2013

Recommendations on biomarker bioanalytical method validation by GCC.

Authors:
Richard Hougton Dominique Gouty John Allinson Rachel Green Mike Losauro Steve Lowes Richard LeLacheur Fabio Garofolo Philippe Couerbe Stéphane Bronner Petra Struwe Christine Schiebl Timothy Sangster Colin Pattison Rafiq Islam Wei Garofolo Maria Pawula Mike Buonarati Roger Hayes Mark Cameron Robert Nicholson Jake Harman Jaap Wieling Theo De Boer Scott Reuschel Laura Cojocaru Tammy Harter Michele Malone William Nowatzke

Bioanalysis 2012 Oct;4(20):2439-46

Quotient Bioresearch, Fordham, UK.

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October 2012

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

Overcoming bioanalytical challenges in an Onglyza(®) intravenous [(14)C]microdose absolute bioavailability study with accelerator MS.

Authors:
Xiaohui Sophia Xu Stephen R Dueker Lisa J Christopher Pete N Lohstroh Chi Fung Anther Keung Kai Kevin Cao Samuel J Bonacorsi Laura Cojocaru Jim X Shen W Griffith Humphreys Bruce Stouffer Mark E Arnold

Bioanalysis 2012 Aug;4(15):1855-70

Research & Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

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August 2012

A sensitive and accurate liquid chromatography-tandem mass spectrometry method for quantitative determination of the novel hepatitis C NS5A inhibitor BMS-790052 (daclastasvir) in human plasma and urine.

Authors:
Hao Jiang Jianing Zeng Hamza Kandoussi Yifei Liu Xiaodong Wang Marc Bifano Laura Cojocaru John Ryan Mark E Arnold

J Chromatogr A 2012 Jul 14;1245:117-21. Epub 2012 May 14.

Bioanalytical Sciences, Bristol-Myers Squibb, Princeton, NJ, USA.

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July 2012

4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover.

Authors:
Steve Lowes Jim Jersey Ronald Shoup Fabio Garofolo Shane Needham Philippe Couerbe Tim Lansing Masood Bhatti Curtis Sheldon Roger Hayes Rafiq Islam Zhongping Lin Wei Garofolo Marc Moussallie Leonardo de Souza Teixeira Thais Rocha Paula Jardieu James Truog Jenny Lin Richard Lundberg Alan Breau Carmen Dilger Mohammed Bouhajib Ann Levesque Sofi Gagnon-Carignan Rand Jenkins Robert Nicholson Ming Hung Lin Shane Karnik William DeMaio Kirk Smith Laura Cojocaru Mike Allen Saadya Fatmi Farhad Sayyarpour Michele Malone Xinping Fang

Bioanalysis 2012 Apr;4(7):763-8

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April 2012

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).

Authors:
Mark Boterman Mira Doig Massimo Breda Steve Lowes Jim Jersey Ronald Shoup Fabio Garofolo Isabelle Dumont Suzanne Martinez Shane Needham Maria Cruz Caturla Philippe Couerbe Joelle Guittard John Maltas Tim Lansing Masood Bhatti Christine Schiebl Petra Struwe Curtis Sheldon Roger Hayes Timothy Sangster Colin Pattison Johanne Bouchard Lee Goodwin Rafiq Islam Rudi Segers Zhongping John Lin Jim Hillier Wei Garofolo Dieter Zimmer Lois Folguera Thomas Zimmermann Maria Pawula Marc Moussallie Leonardo de Souza Teixeira Thais Rocha Daniel Tang Paula Jardieu James Truog Jenny Lin Richard Lundberg Chris Cox Alan Breau Chiara Bigogno Dick Schoutsen Carmen Dilger Mohammed Bouhajib Ann Levesque Sofi Gagnon-Carignan Robert Nicholson Rand Jenkins Ming Hung Lin Shane Karnik Theo De Boer Richard Houghton Rachel Green William DeMaio Romuald Sable Kirk Smith Christoph Siethoff Laura Cojocaru Mike Allen Tammy Harter Saadya Fatmi Farhad Sayyarpour Michele Malone Stuart Best Xinping Fang

Bioanalysis 2012 Mar;4(6):651-60

ABL, Groningen, The Netherlands.

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March 2012

Liquid chromatography and tandem mass spectrometry method for the quantitative determination of saxagliptin and its major pharmacologically active 5-monohydroxy metabolite in human plasma: method validation and overcoming specific and non-specific binding at low concentrations.

Authors:
Xiaohui Sophia Xu Roger Demers Huidong Gu Lisa J Christopher Hong Su Laura Cojocaru David W Boulton Mark Kirby Bruce Stouffer William G Humphreys Mark E Arnold

J Chromatogr B Analyt Technol Biomed Life Sci 2012 Mar 6;889-890:77-86. Epub 2012 Feb 6.

Research & Development, Bristol-Myers Squibb, Princeton, NJ 08543, USA.

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March 2012

Dalbavancin: Quantification in human plasma and urine by a new improved high performance liquid chromatography-tandem mass spectrometry method.

Authors:
Tanja Alebic-Kolbah Roger Demers Laura Cojocaru

J Chromatogr B Analyt Technol Biomed Life Sci 2011 Sep 26;879(25):2632-41. Epub 2011 Jul 26.

Pfizer Inc., Clinical Pharmacology, 445 Eastern Point Road, Groton, CT 06340 United States.

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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.

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