نتائج البحث - "Philippe Couerbe"

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GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline

المؤلفون: 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

المصدر: Bioanalysis. 11(18s)

مصطلحات موضوعية: Engineering, Medical education, Validation study, Bioanalysis, business.industry, Event (computing), Clinical Biochemistry, Attendance, Reproducibility of Results, Guidelines as Topic, General Medicine, Guideline, Analytical Chemistry, Medical Laboratory Technology, Research Design, Humans, General Pharmacology, Toxicology and Pharmaceutics, business, Biomarkers

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4f70e570638ab396bb6fddadea18efb8
https://pubmed.ncbi.nlm.nih.gov/31565956

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2

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

المؤلفون: 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

المصدر: Bioanalysis. 9:505-516

مصطلحات موضوعية: Research Report, Bioanalysis, Computer science, Clinical Biochemistry, Stability (learning theory), Guidelines as Topic, Sample (statistics), Bioinformatics, 030226 pharmacology & pharmacy, 01 natural sciences, Chemistry Techniques, Analytical, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, Drug Stability, Acceptance testing, Data integrity, Humans, General Pharmacology, Toxicology and Pharmaceutics, Notice, Data Collection, Matrix stability, 010401 analytical chemistry, General Medicine, Sample stability, 0104 chemical sciences, Medical Laboratory Technology, Engineering management, Pharmaceutical Preparations, Government Regulation, Biomarkers

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1dd221211c9c17d74f26ad79eddd99f3
https://doi.org/10.4155/bio-2017-5000

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3

12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

المؤلفون: 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

المصدر: Bioanalysis. 11(12)

مصطلحات موضوعية: Societies, Scientific, Bioanalysis, Certification, Immunogenicity, Clinical Biochemistry, Oligonucleotides, General Medicine, Computational biology, Flow Cytometry, Chemistry Techniques, Analytical, Mass Spectrometry, Analytical Chemistry, Social Control, Formal, Medical Laboratory Technology, Indicators and Reagents, Business, General Pharmacology, Toxicology and Pharmaceutics

URL الوصول: 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

المؤلفون: 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

المصدر: Bioanalysis. 11(7)

مصطلحات موضوعية: Quality Control, Bioanalysis, Societies, Pharmaceutical, Clinical Biochemistry, Commercial kit, Ligands, 030226 pharmacology & pharmacy, 01 natural sciences, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, White paper, Surveys and Questionnaires, Drug Discovery, Humans, General Pharmacology, Toxicology and Pharmaceutics, health care economics and organizations, End user, 010401 analytical chemistry, General Medicine, Reference Standards, 0104 chemical sciences, Medical Laboratory Technology, Engineering management, ComputingMethodologies_PATTERNRECOGNITION, Contract research organization, Drug development, Pharmaceutical Preparations, Biomarker (medicine), Biological Assay, Business, Reagent Kits, Diagnostic, Biomarkers

URL الوصول: 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

المؤلفون: 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

المصدر: Bioanalysis. 8:487-495

مصطلحات موضوعية: Bioanalysis, Medical education, Best practice, 010401 analytical chemistry, Clinical Biochemistry, Biosimilar, General Medicine, Audit, Bioinformatics, 030226 pharmacology & pharmacy, 01 natural sciences, 0104 chemical sciences, Analytical Chemistry, 03 medical and health sciences, Medical Laboratory Technology, 0302 clinical medicine, Business, General Pharmacology, Toxicology and Pharmaceutics

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::7a683b7b6ce604e8c46e74aad1120a5d
https://doi.org/10.4155/bio.16.16

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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

المؤلفون: Franklin Spriggs, Chris Beaver, Ashley Brant, Daniel Sikkema, Susan Ohorodnik, John Lindsay, Wei Garofolo, Mike Buonarati, Jing Tu, Chad Briscoe, Scott Fountain, James Hulse, Andrew Dinan, Mark E. Arnold, Rafiq Islam, Saadya Fatmi, James Bourdage, Michael E. Brown, Jim Wilfahrt, Edward Tabler, Philippe Couerbe, Anahita Keyhani, Roger Hayes, Ariana Tudoroniu, Adriana Iordachescu, Kelly Colletti, Jennifer Zemo, Natasha Savoie, Jessica St Charles, John Stamatopoulos, Damon Papac, Colin Barry, Vimal Patel, Gene Ray, Bruce Stouffer, John Marcelletti, Jenny Lin, Jennifer Zimmer, Mark Warren, Mathilde Yu, Maria Cruz Caturla, Philip Joyce, Jenifer Vija, Christina Sanchez, Rachel Green, Xinping Fang, Clark V. Williard, Yansheng Liu, Mohammed Bouhajib, Stephanie Cape, Ira DuBey, Masood Khan, George Hristopoulos, Nicola Hughes, Nadine Boudreau, Barry van der Strate, Rabab Tayyem, Jim Datin, Michael Kennedy, Joanne Hayward-Sewell, Edward Wells, Joseph Bower, Christina Satterwhite, Yi Qun Xiao, Jim Yamashita, Corey Nehls, Curtis Sheldon, Dominic Warrino, Allan Xu, Shane Karnik, Ardeshir Khadang

المصدر: Bioanalysis. 10(7)

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbf30d52d324aed76d79809c62501fab
https://pubmed.ncbi.nlm.nih.gov/29701066

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Recommendations on biomarker bioanalytical method validation by GCC

المصدر: Bioanalysis. 4:2439-2446

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1a7efa86c3e8b8c2d918c23722c49ca0
https://doi.org/10.4155/bio.12.197

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Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC)

المصدر: Bioanalysis. 4:1723-1730

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8aad1b765808699e23ef1f0a68dbe9a6
https://doi.org/10.4155/bio.12.172

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Conference Report: 4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover

المصدر: Bioanalysis. 4:763-768

مصطلحات موضوعية: Bioanalysis, business.industry, Clinical Biochemistry, Guidance documents, Nanotechnology, Drugs stability, General Medicine, Public relations, Analytical Chemistry, Outsourcing, Medical Laboratory Technology, Documentation, Agency (sociology), General Pharmacology, Toxicology and Pharmaceutics, business, Reference standards

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::2d71504a9febae5c5f1d0fbf3f07d687
https://doi.org/10.4155/bio.12.48

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

المؤلفون: 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

المصدر: Bioanalysis. 4:651-660

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f9a6e4fba87d49a60578af519fd3172a
https://doi.org/10.4155/bio.12.18

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