Zobrazeno 1 - 10 of 15 pro vyhledávání: '"Philippe Couerbe"'
1
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
Autor: Andrea Wakefield, Barry van der Strate, Elizabeth Groeber, Saadya Fatmi, Jing Tu, John Allinson, Yansheng Liu, Hanna Ritzén, John Kamerud, Maria Cruz Caturla, Phyllis Conliffe, Zhongping John Lin, Rafiq Islam, Kayode Awaiye, Chad Briscoe, Jenny Lin, Javier Torres, James Hulse, Jim Yamashita, Shane Karnik, Anahita Keyhani, Simona Rizea Savu, Yinghe Li, Nicola Hughes, Rabab Tayyem, Patrick Bennett, Mike Buonarati, Laura Cojocaru, Wei Garofolo, Steve Lowes, Prashant Kale, Afshin Safavi, Dominic Warrino, Mohammed Bouhajib, Paul Rhyne, Michele Malone, Stephanie Mowery, Bruce Stouffer, Mathilde Yu, Daniel Tang, Masood Khan, Ira DuBey, Neil Adcock, Nadine Boudreau, Radha Shekar, Ardeshir Khadang, Edward O'Connor, Christina Satterwhite, Edward Tabler, Philippe Couerbe, Ron Shoup, Adriana Iordachescu, Jennifer Zimmer, Eric Thomas, Natasha Savoie, Jenifer Vija, Rhonda Johnson, Stephanie Cape, Clark V. Williard, Christina Sanchez, Kai Kurylak, Chris Beaver, Corey Nehls, James Bourdage, Mohamed Osman, Brent Matthews, Roger Hayes, Luigi Silvestro, Michele Fiscella
Publikováno v: Bioanalysis. 9:505-516
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC member
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1dd221211c9c17d74f26ad79eddd99f3
https://doi.org/10.4155/bio-2017-5000
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2
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Autor: Xinping Fang, Cheikh Kane, Valentine Barra, Dawn Dufield, Marsha Luna, Adriane Spytko, Jerome Bergeron, Corey Nehls, Robert MacNeill, Andrew Dinan, Esme Farley, Scott Reuschel, Hao Wang, Chantal DiMarco, Timothy Sangster, John Stamatopoulos, Shane Karnik, Nadine Boudreau, Kathie Lindley, Sarah Maasjo, Ariana Tudoroniu, Changming Yang, Jennifer Vance, Christina Satterwhite, Hao Feng, Ira DuBey, Jing Shi, Natasha Savoie, Brian K. Hoffpauir, Kurt J. Sales, Travis Harrison, Orlando Bravo, Jenifer Vija, Jason Ambrosius, Ardeshir Khadang, Chad Briscoe, Stephanie Cape, Edward Tabler, Philippe Couerbe, Adriana Iordachescu, Evgueni Fedorov, Jennifer Zimmer, Roger Hayes, Luca Matassa, Michael H. Buonarati, Franklin Spriggs, Stacie McCown, Michael E. Brown, Wei Garofolo, Jenny Lin, John Lindsay, Paul Rhyne, Shelby Anderson, Bruce Stouffer, Rafiq Islam, John Pirro, Edward Wells, Angie Underberg, Saadya Fatmi, Philip Joyce, Shaolian Zhou, Mohammed Bouhajib, Joseph Bower, Hanna Ritzén, Liam Moran
Publikováno v: Bioanalysis. 11(18s)
The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 201
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4f70e570638ab396bb6fddadea18efb8
https://pubmed.ncbi.nlm.nih.gov/31565956
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3
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
Autor: Ira DuBey, Marc Moussallie, Nadia Kulagina, Dave Williams, Corey Nehls, Rabab Tayyem, Michael E. Brown, Wei Garofolo, Edward Tabler, Philippe Couerbe, Ardeshir Khadang, John Lindsay, Michele Malone, Paul Rhyne, Anahita Keyhani, Mark Warren, Jennifer Zimmer, John Stamatopoulos, Sian Estdale, Clark V. Williard, Bruce Stouffer, Eric Thomas, Mathilde Yu, Rafiq Islam, George Hristopoulos, Simona Rizea Savu, Robert MacNeill, Edward Wells, Jenny Lin, Hanna Ritzén, Iohann Boulay, Natasha Savoie, Kayode Awaiye, Vellalore Kakkanaiah, Shane Karnik, Christina Satterwhite, Curtis Sheldon, Amanda Hays, Chad Briscoe, Kathie Lindley, Colin Barry, Yi Qun Xiao, Andrew Dinan, Allan Xu, Luca Matassa, Arron Xu, Lawrence Goodwin, Steve Lowes, Jessica St Charles, Chantal Di Marco, Mohammed Bouhajib, Maria Cruz Caturla, Nicola Hughes, Patrick Bennett, Jenifer Vija, Stephanie Cape, Roger Hayes, Hao Wang, Xinping Fang, James Bourdage, Franklin Spriggs, Chris Beaver
Publikováno v: Bioanalysis. 11(12)
The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanal
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::38c4dbb172c392741c64fb7ad82791fa
https://pubmed.ncbi.nlm.nih.gov/31319683
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4
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
Autor: Mathilde Yu, Michele Malone, John Stamatopoulos, Christina Satterwhite, George Hristopoulos, Simona Rizea Savu, Mohammed Bouhajib, Chad Briscoe, Edward Tabler, Philippe Couerbe, Edward Wells, Ardeshir Khadang, Ira DuBey, Sian Estdale, Mark Warren, Hanna Ritzén, Wei Garofolo, Franklin Spriggs, Arron Xu, Chris Beaver, Jennifer Zimmer, Iohann Boulay, Anahita Keyhani, Kayode Awaiye, Vellalore Kakkanaiah, Curtis Sheldon, Jessica St Charles, Roger Hayes, Patrick Bennett, James Bourdage, Yi Qun Xiao, Marc Moussallie, Sumit Kar, Shane Karnik, Rabab Tayyem, Maria Cruz Caturla, Clark V. Williard, Hao Wang, Nadia Kulagina, Nicola Hughes, Robert MacNeill, Luigi DiMarco, Andrew Dinan, Kathie Lindley, Natasha Savoie, Xinping Fang, Chantal DiMarco, Bruce Stouffer, Jenifer Vija, Corey Nehls, Stephanie Cape, Eric Thomas, John Lindsay, Paul Rhyne, Michael E. Brown, Jenny Lin, Amanda Hays, Allan Xu, Hao Feng, Lawrence Goodwin, Rafiq Islam, Colin Barry, Dave Williams
Publikováno v: Bioanalysis. 11(7)
Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::34219e762535ddd3b0da39d50cd5b1ec
https://pubmed.ncbi.nlm.nih.gov/30993999
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5
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
Autor: Ardeshir Khadang, Elizabeth Groeber, Gunjan Soni, Yi Qun Xiao, Afshin Safavi, Saadya Fatmi, Manon Verville, Daniel Mulvana, Gene Ray, Sarah Harris, Mathilde Yu, Allan Xu, Jenny Lin, Isabelle Dumont, Clare Kingsley, Mike Buonarati, Nico C van de Merbel, Masood Khan, Natasha Savoie, Ian Ward, Luigi Silvestro, Michele Fiscella, Nadine Boudreau, Curtis Sheldon, Jaap Wieling, Richard LeLacheur, Christina Satterwhite, Benno Ingelse, Anahita Keyhani, Shane Karnik, Kai Kurylak, Ann Lévesque, Roger Hayes, Bob Nicholson, Rafiq Islam, Mike Allen, Jennifer Zimmer, Edward Tabler, Philippe Couerbe, Colin Pattison, Xinping Fang, Lorella Di Donato, Zhongping John Lin, Mario Rocci, Manju Saxena, Yansheng Liu, Ron Shoup, Patrick Bennett, Wei Garofolo, Laura Cojocaru, Stephanie Cape, Maria Cruz Caturla, Nicola Hughes, Jennifer Bravo, James Bourdage, Michele Malone, Chad Briscoe, James Hulse, Hanna Ritzén, Mohammed Bouhajib
Publikováno v: Bioanalysis. 8:487-495
The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7a683b7b6ce604e8c46e74aad1120a5d
https://doi.org/10.4155/bio.16.16
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8
Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Autor: Jim Hillier, Chiara Bigogno, Mira Doig, Mike Allen, Theo de Boer, Mohammed Bouhajib, Chris Cox, Ronald Shoup, Dieter Zimmer, Roger Hayes, John Maltas, Masood Bhatti, Maria Cruz Caturla, Michele Malone, Jim Jersey, Timothy Sangster, Romuald Sable, Massimo Breda, Philippe Couerbe, Saadya Fatmi, Lois Folguera, Lee Goodwin, Alan Breau, Daniel Tang, Paula Jardieu, Shane Karnik, Ann Levesque, Dick Schoutsen, Isabelle Dumont, Zhongping John Lin, Wei Garofolo, Ming Hung Lin, Johanne Bouchard, Xinping Fang, Christine Schiebl, Curtis Sheldon, Carmen Dilger, Steve Lowes, Joelle Guittard, Petra Struwe, Suzanne Martinez, Mark Boterman, Maria Pawula, Shane Needham, Fabio Garofolo, Tim Lansing, Richard Houghton, Marc Moussallie, William DeMaio, Jenny Lin, Tammy Harter, Laura Cojocaru, Kirk R. Smith, Colin Pattison, Rand Jenkins, Richard Lundberg, Rachel Green, Robert Nicholson, Leonardo de Souza Teixeira, James Truog, Stuart Best, Farhad Sayyarpour, Rafiq Islam, Rudi Segers, Christoph Siethoff, Thais Rocha, Thomas Zimmermann, Sofi Gagnon-Carignan
Publikováno v: Bioanalysis. 4:651-660
Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA)
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f9a6e4fba87d49a60578af519fd3172a
https://doi.org/10.4155/bio.12.18
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9
Conference Report: The 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum
Autor: Dick Schoutsen, Tammy Harter, Quinton Claassen, Rachel Green, Bernard Jeanbaptiste, Eileen Collins, Wei Garofolo, Philippe Couerbe, Fabio Garofolo, Mark Seymour, Petra Struwe, Maria Cruz Caturla, Peter White, Jim Hillier, Jaap Wieling, Suzanne Riches, Richard Houghton, John Maltas, Massimo Breda, Maria Pawula, Timothy Sangster, Thomas Zimmerman
Publikováno v: Bioanalysis. 3:2721-2727
The 3rd Global CRO Council Closed Forum was held on the 3rd and 4th July 2011 in Guildford, United Kingdom, in conjunction with the 19th International Reid Bioanalytical Forum. In attendance were 21 senior-level representatives from 19 CROs on behalf
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::251089e96d77847b770dfad086186855
https://doi.org/10.4155/bio.11.242
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10
Validated LC–MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma
Autor: Jinnan Cai, Anne-Françoise Aubry, Xiaohui Xu, Mark Tirmenstein, Bonnie Wang, Yuzhong Deng, Huidong Gu, Ling Morgan, Philippe Couerbe, Mark E. Arnold, Reynald Magnier
Publikováno v: Bioanalysis. 2:2001-2009
Background: Dapagliflozin is an inhibitor of sodium-glucose co-transporter 2 (SGLT-2) in development for the treatment of Type 2 diabetes. To support toxicology studies, LC–MS/MS methods were developed and validated for the quantitation of dapaglif
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::096b843cca469f47215187ea386a214b
https://doi.org/10.4155/bio.10.139
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