Publications by authors named "Mike Buonarati"

10 Publications

  • Page 1 of 1

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.

View Article and Find Full Text PDF
September 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.

View Article and Find Full Text PDF
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.

View Article and Find Full Text PDF
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.

View Article and Find Full Text PDF
March 2016

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.

View Article and Find Full Text PDF
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.

View Article and Find Full Text PDF
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.

View Article and Find Full Text PDF
September 2014

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.

View Article and Find Full Text PDF
October 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.

View Article and Find Full Text PDF
June 2011

Formation of a Global Contract Research Organization Council for Bioanalysis.

Authors:
Noel Premkumar Stephen Lowes James Jersey Fabio Garofolo Isabelle Dumont Robert Masse Betty Stamatiou Maria C Caturla Ray Steffen Michele Malone Elliot Offman Timothy Samuels Phillip Oldfield Lorella Di Donato Douglas Fast Daniel Tang Marc Moussallie John Doughty Mario Rocci Mike Buonarati Dominique Gouty Darioush Dadgar John Stamatopoulos Alan Breau Bernard Ntsikoussalabongui Mohammed Bouhajib Bob Nicholson Richard Tacey Peter Ketelaar Chad Briscoe Shane Karnik Jaap Wieling Jon Kirk Smith Michael J Reid Richard Lelacheur John Chapdelaine Saadya Fatmi Farhad Sayyarpour Xinping Fang Jeremy Cook David Browne

Bioanalysis 2010 Nov;2(11):1797-800

View Article and Find Full Text PDF
November 2010