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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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2
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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3
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
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4
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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5
المؤلفون: Isabelle A. Lévesque, Ann Lévesque, Aimin Tan, Nadine Boudreau, Sylvain Lachance, Sébastien Gagné
المصدر: Journal of Chromatography B. 901:79-84
مصطلحات موضوعية: Male, Erythrocytes, Clinical Biochemistry, Methazolamide, Hemolysis, Biochemistry, Analytical Chemistry, medicine, Humans, Blood Specimen Collection, Chromatography, Plasma samples, Chemistry, Erythrocyte fragility, Reproducibility of Results, Cell Biology, General Medicine, medicine.disease, Red blood cell, medicine.anatomical_structure, Drug concentration, Pharmaceutical Preparations, Research Design, Plasma concentration, Female, Sample collection, Blood Chemical Analysis, medicine.drug
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6
المؤلفون: Caroline Savard, Nadine Boudreau, Ann Lévesque, Nathalie Pelletier, James S. Bernstein, Om Dhingra, Sylvain Lachance, Stéphanie Gagnon
المصدر: Future Science OA
مصطلحات موضوعية: medicine.medical_specialty, medicine.medical_treatment, enzyme inhibitor, Pharmacology, Internal medicine, Medicine, Testosterone, Whole blood, chemistry.chemical_classification, Oral testosterone, biology, Plasma samples, business.industry, method validation, Clinical trial, Enzyme, Endocrinology, hydrolysis, chemistry, Enzyme inhibitor, testosterone, biology.protein, Androgen replacement therapy, business, testosterone undecanoate, Research Article, Biotechnology
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7
المؤلفون: Ann Levesque, Isabelle A. Lévesque, Aimin Tan, François Viel, Isabelle Lévesque, Nadine Boudreau
المصدر: Journal of Chromatography B. 879:1954-1960
مصطلحات موضوعية: Analyte, Bioanalysis, Internal standard, Calibration curve, Clinical Biochemistry, Nipecotic Acids, Analytical chemistry, Sensitivity and Specificity, Biochemistry, Signal, Mass Spectrometry, Analytical Chemistry, Matrix (chemical analysis), Liquid chromatography–mass spectrometry, Humans, Computer Simulation, Least-Squares Analysis, Tiagabine, Chromatography, Chemistry, Reproducibility of Results, Linearity, Cell Biology, General Medicine, Reference Standards, Chromatography, Liquid
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8
المؤلفون: Nadine Boudreau, Saadya Fatmi, Richard LeLacheur, Raymond Farmen, John Allinson, Mohammed Bouhajib, Tianyi Zhang, Mike Buonarati, Ronald Shoup, Mary Stipancic, Brigitte Pellerin, Philippe Couerbe, Joseph Bower, Stephanie Cape, Michelle Fiscella, Marc Moussallie, Jim Hulse, Robert Ian Nicholson, Stephanie Pasas-Farmer, Ian E. Smith, Jennifer Zimmer, Mark Warren, Andrea Watson, John Kamerud, Douglas M. Fast, Allan Xu, Laura Cojocaru, Scott Reuschel, Isabelle Dumont, Jenny Lin, Dominique Gouty, Mario Rocci, Fabio Garofolo, Steve Lowes, Curtis Sheldon, Richard Houghton, Craig Stovold, Xinping Fang, Kayode Awaiye, Roger Hayes, Shane Karnik, Corey Nehls, John Marcelletti, Maria Cruz Caturla, Wei Garofolo
المصدر: Bioanalysis. 6(20)
مصطلحات موضوعية: business.industry, Clinical Laboratory Techniques, Clinical Biochemistry, Attendance, Guidelines as Topic, Hyperlipidemias, General Medicine, Public relations, Analytical Chemistry, Outsourcing, Medical Laboratory Technology, Political science, Electronic Health Records, Humans, General Pharmacology, Toxicology and Pharmaceutics, business, Biomarkers
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9
المؤلفون: Saadya Fatmi, Mary Stipancic, Roger Hayes, Andrea Watson, Tee Zhang, Laura Cojocaru, John Allinson, Stephanie Pasas-Farmer, Kayode Awaiye, Shane Karnik, Douglas M. Fast, John Kamerud, Steve Lowes, Mohammed Bouhajib, Michele Fiscella, Ian E. Smith, Dominique Gouty, Ronald Shoup, John Marcelletti, Isabelle Dumont, Raymond Farmen, Mike Buonarati, Xinping Fang, Nadine Boudreau, Joseph Bower, Curtis Sheldon, Philippe Couerbe, Richard LeLacheur, Marc Moussallie, Jim Hulse, Stephanie Cape, Jenny Lin, Mark Warren, Jennifer Zimmer, Richard Houghton, Craig Stovold, Fabio Garofolo, Scott Reuschel, Corey Nehls, Mario Rocci, Suzanne Martinez, Brigitte Pellerin, Maria Cruz Caturla, Wei Garofolo, Robert Ian Nicholson, Allan Xu
المصدر: Bioanalysis. 6(18)
مصطلحات موضوعية: business.industry, Data Collection, Clinical Biochemistry, Reproducibility of Results, Context (language use), Nanotechnology, Survey result, Accounting, Clinical Chemistry Tests, General Medicine, Method development, Sample stability, Analytical Chemistry, Medical Laboratory Technology, Political science, General Pharmacology, Toxicology and Pharmaceutics, business
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10
المؤلفون: Jean Legault, Michèle Auger, Audrey Saint-Laurent, René C.-Gaudreault, Dominic Larivière, Nadine Boudreau
المصدر: Chemistry and Physics of Lipids. 111:163-175
مصطلحات موضوعية: Chemical Phenomena, Stereochemistry, Lipid Bilayers, Substituent, Antineoplastic Agents, In Vitro Techniques, Branching (polymer chemistry), Biochemistry, Structure-Activity Relationship, chemistry.chemical_compound, Spectroscopy, Fourier Transform Infrared, Urea, Fourier transform infrared spectroscopy, Lipid bilayer, Molecular Biology, POPC, Alkyl, chemistry.chemical_classification, Liposome, Chemistry, Physical, Bilayer, Cell Membrane, Organic Chemistry, Membranes, Artificial, Phosphatidylglycerols, Cell Biology, chemistry, Phosphatidylcholines, Thermodynamics, lipids (amino acids, peptides, and proteins), Dimyristoylphosphatidylcholine