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11 research outputs found
Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover
Author
Alan Breau
Ann Levesque
+36Â more
Boterman
Carmen Dilger
Curtis Sheldon
Fabio Garofolo
Farhad Sayyarpour
James Truog
Jenny Lin
Jim Jersey
Kirk Smith
Laura Cojocaru
Leonardo de Souza Teixeira
Marc Moussallie
Masood Bhatti
Michele Malone
Mike Allen
Ming Hung Lin
Mohammed Bouhajib
Paula Jardieu
Philippe Couerbe
Rafiq Islam
Rand Jenkins
Richard Lundberg
Robert Nicholson
Roger Hayes
Ronald Shoup
Saadya Fatmi
Shane Karnik
Shane Needham
Sofi Gagnon-Carignan
Steve Lowes
Thais Rocha
Tim Lansing
Wei Garofolo
William DeMaio
Xinping Fang
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing
Author
Allan Xu
Andrea Watson
+45Â more
Brigitte Pellerin
Corey Nehls
Craig Stovold
Curtis Sheldon
Dominique Gouty
Douglas Fast
European Medicines Agency
Fabio Garofolo
FDA
Ian Smith
Isabelle Dumont
Jennifer Zimmer
Jenny Lin
Jim Hulse
John Allinson
John Kamerud
John Marcelletti
Joseph Bower
Kayode Awaiye
Laura Cojocaru
Marc Moussallie
Maria Cruz Caturla
Mario Rocci
Mark Warren
Mary Stipancic
Michelle Fiscella
Mike Buonarati
Mohammed Bouhajib
Nadine Boudreau
Philippe Couerbe
Raymond Farmen
Richard Houghton
Richard LeLacheur
Robert Nicholson
Roger Hayes
Ronald Shoup
Saadya Fatmi
Scott Reuschel
Shane Karnik
Stephanie Cape
Stephanie Pasas-Farmer
Steve Lowes
Tianyi Zhang
Wei Garofolo
Xinping Fang
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Author
Afshin Safavi
Allan Xu
+45Â more
Andrew Dinan
Ann Levesque
Curtis Sheldon
Dan Mamelak
Daniel Tang
Dominique Gouty
Douglas Fast
Douglas Turk
Hougton
Isabelle Dumont
Jake Harman
James Petrilla
Jenifer Vija
Jennifer Zimmer
Jenny Lin
John Allinson
John Kamerud
Kayode Awaiye
Laura Cojocaru
Laura Wright
Maria Cruz Caturla
Marie Rock
Mark Warren
Masood Khan
Michele Malone
Mohammed Bouhajib
Pilar Gonzalez
Rafiq Islam
Ray Steffen
Richard LeLacheur
Robert Nicholson
Roger Hayes
Ronald Shoup
Saadya Fatmi
Scott Reuschel
Shane Karnik
Sofi Gagnon-Carignan
Steve Lowes
Suzanne Martinez
Wei Garofolo
William Nowatzke
Xinping Fang
Yansheng Liu
Yasuhiro Yamashita
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
Author
Alan Breau
Corey Nehls
+43Â more
Curtis Sheldon
Dennis Heller
Ejvind Mortz
Fabio Garofolo
Farhad Sayyarpour
James Truog
Jenifer Vija
Jianine Jonker
Jim Hillier
Jim Jersey
John Kamerud
Kirk Smith
Laura Cojocaru
Leonardo de Souza Teixeira
Lorella Di Donato
Marc Moussallie
Maria Cruz Caturla
Mario Rocci
Martijn Hilhorst
Michele Malone
Mike Allen
Mike Buonarati
Natasha Savoie
Neil Berger
Ray Steffen
Richard Houghton
Richard Lundberg
Robert Nicholson
Roger Hayes
Ronald Shoup
Saadya Fatmi
Saleh Hussain
Shah
Shane Karnik
Shane Needham
Sofi Gagnon-Carignan
Steve Lowes
Steve Michael
Tammy Harter
Theo de Boer
Tianyi Zhang
Tim Samuels
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
Recommendations on incurred sample stability (ISS) by GCC
Author
Allan Xu
Andrea Watson
+46Â more
Brigitte Pellerin
Corey Nehls
Craig Stovold
Curtis Sheldon
Dominique Gouty
Douglas Fast
European Medicines Agency Committee for Medicinal Products for Human Use (CHMP)
Fabio Garofolo
Ian Smith
Isabelle Dumont
Jennifer Zimmer
Jenny Lin
Jim Hulse
John Allinson
John Kamerud
John Marcelletti
Joseph Bower
Kayode Awaiye
Laura Cojocaru
Marc Moussallie
Maria Cruz Caturla
Mario Rocci
Mark Warren
Mary Stipancic
Michele Fiscella
Mike Buonarati
Mohammed Bouhajib
Nadine Boudreau
Philippe Couerbe
Raymond Farmen
Richard Houghton
Richard LeLacheur
Robert Nicholson
Roger Hayes
Ronald Shoup
Saadya Fatmi
Scott Reuschel
Shane Karnik
Stephanie Cape
Stephanie Pasas-Farmer
Steve Lowes
Suzanne Martinez
Tee Zhang
US FDA
Wei Garofolo
Xinping Fang
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
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
Author
Afshin Safavi
Allan Xu
+58Â more
Anahita Keyhani
Ann Lévesque
Ardeshir Khadang
Benno Ingelse
Bob Nicholson
Chad Briscoe
Christina Satterwhite
Clare Kingsley
Colin Pattison
Curtis Sheldon
Daniel Mulvana
Edward Tabler
Elizabeth Groeber
Gene Ray
Gunjan Soni
Hanna Ritzén
Ian Ward
Isabelle Dumont
Jaap Wieling
James Bourdage
James Hulse
Jennifer Bravo
Jennifer Zimmer
Jenny Lin
Kai Kurylak
Laura Cojocaru
Lorella Di Donato
Luigi Silvestro
Manju Saxena
Manon Verville
Maria Cruz Caturla
Mario Rocci
Masood U Khan
Mathilde Yu
Michele Fiscella
Michele Malone
Mike Allen
Mike Buonarati
Mohammed Bouhajib
Nadine Boudreau
Natasha Savoie
Nico van de Merbel
Nicola Hughes
Patrick Bennett
Philippe Couerbe
Rafiq Islam
Richard LeLacheur
Roger Hayes
Ron Shoup
Saadya Fatmi
Sarah Harris
Shane Karnik
Stephanie Cape
Wei Garofolo
Xinping Fang
Yansheng Liu
Yi Qun Xiao
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Author
Adriana Iordachescu
Adriane Spytko
+63Â more
Andrew Dinan
Angie Underberg
Ardeshir Khadang
Ariana Tudoroniu
Brian Hoffpauir
Bruce Stouffer
Chad Briscoe
Changming Yang
Chantal DiMarco
Cheikh Kane
Christina Satterwhite
Corey Nehls
Dawn Dufield
Edward Tabler
Edward Wells
Esme Farley
Evgueni Fedorov
Franklin Spriggs
Hanna Ritzén
Hao Feng
Hao Wang
Ira DuBey
Jason Ambrosius
Jenifer Vija
Jennifer Vance
Jennifer Zimmer
Jenny Lin
Jerome Bergeron
Jing Shi
John Lindsay
John Pirro
John Stamatopoulos
Joseph Bower
Kathie Lindley
Kurt Sales
Liam Moran
Luca Matassa
Marsha Luna
Michael Brown
Michael Buonarati
Mohammed Bouhajib
Nadine Boudreau
Natasha Savoie
Orlando Bravo
Paul Rhyne
Philip Joyce
Philippe Couerbe
Rafiq Islam
Robert MacNeill
Roger Hayes
Saadya Fatmi
Sarah Maasjo
Scott Reuschel
Shane Karnik
Shaolian Zhou
Shelby Anderson
Stacie McCown
Stephanie Cape
Timothy Sangster
Travis Harrison
Valentine Barra
Wei Garofolo
Xinping Fang
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Author
Alan Breau
Ann Levesque
+66Â more
Carmen Dilger
Chiara Bigogno
Chris Cox
Christine Schiebl
Christoph Siethoff
Colin Pattison
Curtis Sheldon
Daniel Tang
Dick Schoutsen
Dieter Zimmer
Fabio Garofolo
Farhad Sayyarpour
Isabelle Dumont
James Truog
Jenny Lin
Jim Hillier
Jim Jersey
Joelle Guittard
Johanne Bouchard
John Maltas
Kirk Smith
Laura Cojocaru
Lee Goodwin
Leonardo de Souza Teixeira
Lois Folguera
Marc Moussallie
Maria Cruz Caturla
Maria Pawula
Mark Boterman
Masood Bhatti
Massimo Breda
Michele Malone
Mike Allen
Ming Hung Lin
Mira Doig
Mohammed Bouhajib
Paula Jardieu
Petra Struwe
Philippe Couerbe
Rachel Green
Rafiq Islam
Rand Jenkins
Richard Houghton
Richard Lundberg
Robert Nicholson
Roger Hayes
Romuald Sable
Ronald Shoup
Rudi Segers
Saadya Fatmi
Shane Karnik
Shane Needham
Sofi Gagnon-Carignan
Steve Lowes
Stuart Best
Suzanne Martinez
Tammy Harter
Thais Rocha
Theo De Boer
Thomas Zimmermann
Tim Lansing
Timothy Sangster
Wei Garofolo
William DeMaio
Xinping Fang
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
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
Author
Adriana Iordachescu
Allan Xu
+70Â more
Anahita Keyhani
Andrew Dinan
Ardeshir Khadang
Ariana Tudoroniu
Ashley Brant
Barry van der Strate
Bruce Stouffer
Chad Briscoe
Chris Beaver
Christina Sanchez
Christina Satterwhite
Clark Williard
Colin Barry
Corey Nehls
Curtis Sheldon
Damon Papac
Daniel Sikkema
Dominic Warrino
Edward Tabler
Edward Wells
Franklin Spriggs
Gene Ray
George Hristopoulos
Ira DuBey
James Bourdage
James Hulse
Jenifer Vija
Jennifer Zemo
Jennifer Zimmer
Jenny Lin
Jessica St Charles
Jim Datin
Jim Wilfahrt
Jim Yamashita
Jing Tu
Joanne Hayward-Sewell
John Lindsay
John Marcelletti
John Stamatopoulos
Joseph Bower
Kelly Colletti
Maria Cruz Caturla
Mark Arnold
Mark Warren
Masood Khan
Mathilde Yu
Michael Brown
Michael Kennedy
Mike Buonarati
Mohammed Bouhajib
Nadine Boudreau
Natasha Savoie
Nicola Hughes
Philip Joyce
Philippe Couerbe
Rabab Tayyem
Rachel Green
Rafiq Islam
Roger Hayes
Saadya Fatmi
Scott Fountain
Shane Karnik
Stephanie Cape
Susan Ohorodnik
Vimal Patel
Wei Garofolo
Welink J
Xinping Fang
Yansheng Liu
Yi Qun Xiao
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)
Author
Afshin Safavi
Alan Breau
+90Â more
Allan Xu
Andrew Dinan
Ann Levesque
Carmen Dilger
Chiara Bigogno
Chris Cox
Christine Schiebl
Christoph Siethoff
Colin Pattison
Curtis Sheldon
Dan Mamelak
Daniel Tang
DeSilva
Dick Schoutsen
Dieter Zimmer
Dominique Gouty
Douglas Fast
Douglas Turk
Fabio Garofolo
Farhad Sayyarpour
Isabelle Dumont
Jake Harman
James Petrilla
James Truog
Jenifer Vija
Jennifer Zimmer
Jenny Lin
Jianine Jonker
Jim Hillier
Jim Jersey
John Allinson
John Kamerud
John Maltas
Kayode Awaiye
Kirk Smith
Laura Cojocaru
Laura Wright
Lee Goodwin
Leonardo de Souza Teixeira
Lois Folguera
Marc Moussallie
Maria Cruz Caturla
Maria Pawula
Marie Rock
Mark Boterman
Mark Warren
Masood Bhatti
Masood Khan
Massimo Breda
Michele Malone
Mike Allen
Ming Hung Lin
Mira Doig
Mohammed Bouhajib
Paula Jardieu
Petra Struwe
Philippe Couerbe
Pilar Gonzalez
Rachel Green
Rafiq Islam
Rand Jenkins
Ray Steffen
Richard Houghton
Richard LeLacheur
Richard Lundberg
Robert Nicholson
Roger Hayes
Romuald Sable
Ronald Shoup
Rudi Segers
Saadya Fatmi
Scott Reuschel
Shane Karnik
Shane Needham
Sofi Gagnon-Carignan
Steve Lowes
Stuart Best
Suzanne Martinez
Tammy Harter
Thais Rocha
Theo De Boer
Thomas Zimmermann
Timothy Sangster
Wei Garofolo
William DeMaio
William Nowatzke
Xinping Fang
Yansheng Liu
Yasuhiro Yamashita
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref
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