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1GCC 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
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2Incurred sample reproducibility in pharmacokinetic bioanalysis: pros and cons from a CRO perspective
المؤلفون: Brittany Maria Timmons, Laura Hay, Bruce Stouffer, Jim Gorman
المصدر: Bioanalysis. 10:1715-1717
مصطلحات موضوعية: Bioanalysis, medicine.medical_specialty, Computer science, Clinical Biochemistry, Sample (statistics), Validation Studies as Topic, 030226 pharmacology & pharmacy, 01 natural sciences, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, Drug Development, medicine, Animals, Humans, Pharmacokinetics, Medical physics, General Pharmacology, Toxicology and Pharmaceutics, Reproducibility, United States Food and Drug Administration, 010401 analytical chemistry, Perspective (graphical), cons, Reproducibility of Results, General Medicine, United States, 0104 chemical sciences, Medical Laboratory Technology
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3
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
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4
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
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5
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
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6
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)
مصطلحات موضوعية: Bioanalysis, China, Computer science, Matrix stability, 010401 analytical chemistry, Clinical Biochemistry, Biosimilar, General Medicine, 030226 pharmacology & pharmacy, 01 natural sciences, 0104 chemical sciences, Analytical Chemistry, Food and drug administration, 03 medical and health sciences, Medical Laboratory Technology, Engineering management, 0302 clinical medicine, Research Design, Humans, Biological Assay, Sample collection, General Pharmacology, Toxicology and Pharmaceutics, Laboratory Manuals, Biosimilar Pharmaceuticals, Biomarkers
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7
المؤلفون: Pekka Kurki, Robert Neely, Akiko Ishii-Watabe, Soma Ray, Yanhua Zhang, Giane Sumner, Susan M. Richards, Lorella Di Donato, Roland F Staack, Charles S Hottenstein, Seongeun Julia Cho, Saloumeh K Fischer, Lauren Stevenson, Jim McNally, Jonathan Haulenbeek, Lilian Yengi, John Smeraglia, Boris Gorovits, Yuanxin Xu, Jenny Hu, Joe Bower, Ashley Mullan, Yan Zhang, Rafiq Islam, Daniel Kramer, Tong-Yuan Yang, John Kadavil, Flora Berisha, Barry van der Strate, Linglong Zou, Laurent Cocea, Kay-Gunnar Stubenrauch, Gerry Kolaitis, Renuka Pillutla, Lakshmi Amaravadi, Thorsten Verch, Chris Beaver, John Kamerud, Marianne Scheel Fjording, Fabio Garofolo, Xuemei Zhao, Yoshiro Saito, Shashi Amur, An Song, Stephen J. Zoog, Kara Scheibner, João Pedras-Vasconcelos, Natasha Savoie, Sam Haidar, Bruce Stouffer, Isabelle Cludts, Binodh DeSilva, Jianing Zeng, Montserrat Carrasco-Triguero, Afshin Safavi, Apollon Papadimitriou, Darshana Jani, Isabella Berger, Michael A Partridge, Jan Welink, Shalini Gupta, Devangi Mehta, Stephen MacMannis, Herbert Birnboeck, Nilufer Tampal, Steven P. Piccoli, Stephanie Fraser
المصدر: Bioanalysis. 9(24)
مصطلحات موضوعية: Bioanalysis, Consensus Development Conferences as Topic, Clinical Biochemistry, Guidelines as Topic, Ligands, 030226 pharmacology & pharmacy, 01 natural sciences, Mass Spectrometry, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, White paper, Political science, Pharmacokinetics, General Pharmacology, Toxicology and Pharmaceutics, Immunogenicity, 010401 analytical chemistry, Scientific excellence, General Medicine, Drug Tolerance, 0104 chemical sciences, Medical Laboratory Technology, Biopharmaceutical, Immunity, Active, Engineering ethics, Biomarkers, Chromatography, Liquid
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8
المؤلفون: William Mylott, Jim X Shen, Shenita Basdeo, Xiaohui Xu, Anne-Françoise Aubry, David W. Boulton, Guowen Liu, Bruce Stouffer, Mark E. Arnold, Qin C Ji, Eric Ma, Jane Liu
المصدر: Analytical Chemistry. 87:3247-3254
مصطلحات موضوعية: Spectrometry, Mass, Electrospray Ionization, Bioanalysis, Chromatography, Electrospray ionization, Metabolite, Analytic Sample Preparation Methods, Reproducibility of Results, Assay sensitivity, Acetates, Tandem mass spectrometry, Mass spectrometry, Analytical Chemistry, chemistry.chemical_compound, Glucosides, chemistry, Tandem Mass Spectrometry, Humans, Sample preparation, Benzhydryl Compounds, Dapagliflozin, Blood Chemical Analysis
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9
المؤلفون: Li Xue, Mark J. Rose, Eric Woolf, Lauren Stevenson, Tong-Yuan Yang, Ann Lévesque, Olivier Le Blaye, Annik Bergeron, Jian Wang, Laura Cojocaru, Mark E. Arnold, Mark Bustard, Josée Michon, Daksha Desai-Krieger, Neil Spooner, John Smeraglia, Mary Carbone, Benno Ingelse, Eric Fluhler, Heather Myler, Jan Welink, Ronald Bauer, Tom Verhaeghe, Adrien Musuku, Faye Vazvaei, Fabio Garofolo, Isabelle Dumont, Jason Wakelin-Smith, Shefali Patel, Gary Schultz, Xiao-Yan Cai, Noriko Katori, Sam Haidar, Mark Ma, Emma Whale, Amanda Wilson, Timothy V Olah, Roger Hayes, Bruce Stouffer, Jeff Duggan, Steve Lowes, Katalina Mettke, Surendra Bansal, Stacy Ho
المصدر: Bioanalysis. 6:3039-3049
مصطلحات موضوعية: Validation study, Engineering, Bioanalysis, business.industry, Clinical Biochemistry, Scientific excellence, Nanotechnology, General Medicine, Analytical Chemistry, Medical Laboratory Technology, White paper, Engineering ethics, General Pharmacology, Toxicology and Pharmaceutics, business
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10
المؤلفون: Mark E. Arnold, Xiaohui Xu, Mohammed Jemal, Qin C Ji, Bruce Stouffer, Jim X Shen, Carol Gleason
المصدر: Bioanalysis. 5:83-90
مصطلحات موضوعية: Research Report, Bioanalysis, Computer science, Statistics as Topic, Clinical Biochemistry, Clinical Chemistry Tests, Nanotechnology, General Medicine, Validation Studies as Topic, Data science, Analytical Chemistry, Medical Laboratory Technology, Tandem Mass Spectrometry, Lc ms ms, Humans, General Pharmacology, Toxicology and Pharmaceutics, Chromatography, Liquid