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7 research outputs found
Some unnecessary or inadequate common practices in regulated LC–MS bioanalysis
Author
Aimin Tan
Fethi Trabelsi
Kayode Awaiye
Tan A
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
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
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
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
Author
Allan Xu
Amanda Hays
+60Â more
Anahita Keyhani
Andrew Dinan
Ardeshir Khadang
Arron Xu
Bruce Stouffer
Chad Briscoe
Chantal Di Marco
Chris Beaver
Christina Satterwhite
Clark Williard
Colin Barry
Corey Nehls
Curtis Sheldon
Dave Williams
Edward Tabler
Edward Wells
Eric Thomas
Franklin Spriggs
George Hristopoulos
Hanna Ritzén
Hao Wang
Iohann Boulay
Ira DuBey
James Bourdage
Jenifer Vija
Jennifer Zimmer
Jenny Lin
Jessica St Charles
John Lindsay
John Stamatopoulos
Kathie Lindley
Kayode Awaiye
Lawrence Goodwin
Luca Matassa
Marc Moussallie
Maria Cruz Caturla
Mark Warren
Mathilde Yu
Michael Brown
Michele Malone
Mohammed Bouhajib
Nadia Kulagina
Natasha Savoie
Nicola Hughes
Patrick Bennett
Paul Rhyne
Philippe Couerbe
Rabab Tayyem
Rafiq Islam
Robert MacNeill
Roger Hayes
Shane Karnik
Sian Estdale
Simona Rizea Savu
Stephanie Cape
Steve Lowes
Vellalore Kakkanaiah
Wei Garofolo
Xinping Fang
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
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
Author
Adriana Iordachescu
Afshin Safavi
+75Â more
Anahita Keyhani
Andrea Wakefield
Ardeshir Khadang
Barry van der Strate
Brent Matthews
Bruce Stouffer
Chad Briscoe
Chris Beaver
Christina Sanchez
Christina Satterwhite
Clark Williard
Corey Nehls
Daniel Tang
Dominic Warrino
Edward O'Connor
Edward Tabler
Elizabeth Groeber
Eric Thomas
European Medicines Agency Committee for Medicinal Products for Human Use (CHMP)
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP)
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP)
Hanna Ritzen
Ira DuBey
James Bourdage
James Hulse
Javier Torres
Jenifer Vija
Jennifer Zimmer
Jenny Lin
Jim Yamashita
Jing Tu
John Allinson
John Kamerud
Kai Kurylak
Kayode Awaiye
Laura Cojocaru
Luigi Silvestro
Maria Cruz Caturla
Masood Khan
Mathilde Yu
Medicines and Healthcare products Regulatory Agency
Michele Fiscella
Michele Malone
Mike Buonarati
Mohamed Osman
Mohammed Bouhajib
Nadine Boudreau
Natasha Savoie
Neil Adcock
Nicola Hughes
Organisation for Economic Co-operation and Development Environment Directorate Chemicals Group and Management Committee
Patrick Bennett
Paul Rhyne
Philippe Couerbe
Phyllis Conliffe
Prashant Kale
Rabab Tayyem
Radha Shekar
Rafiq Islam
Rhonda Johnson
Roger Hayes
Ron Shoup
Saadya Fatmi
Shane Karnik
Simona Rizea Savu
Stephanie Cape
Stephanie Mowery
Steve Lowes
US Department of Health and Human Services US FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM)
US Department of Health and Human Services US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine
US Department of Health and Human Services US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine
Wei Garofolo
Yansheng Liu
Yinghe Li
Zhongping (John) Lin
Publication venue
'Future Science Ltd'
Publication date
Field of study
No full text
Crossref