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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: 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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3
المؤلفون: Simona Nicoleta Savu, Simona Rizea Savu, Ariana Tudoroniu, Isabela Tarcomnicu, Luigi Silvestro
المصدر: Biomedical Chromatography. 26:627-635
مصطلحات موضوعية: Pharmacology, Chromatography, Chemistry, Electrospray ionization, Clinical Biochemistry, Extraction (chemistry), Analytical chemistry, General Medicine, Mass spectrometry, Tandem mass spectrometry, Biochemistry, Fluticasone propionate, Analytical Chemistry, Liquid chromatography–mass spectrometry, Drug Discovery, medicine, Sample preparation, Salmeterol, Molecular Biology, medicine.drug
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4
المؤلفون: Luigi Silvestro, Isabela Tarcomnicu, Adriana Iordachescu, Simona Rizea Savu, Ariana Tudoroniu, Valentin Ciuca, Mihaela Gheorghe
المصدر: Analytical and Bioanalytical Chemistry. 401:1023-1034
مصطلحات موضوعية: Analyte, Ticlopidine, Chromatography, Chemistry, Metabolite, Acyl glucuronide, Reproducibility of Results, Clopidogrel, Biochemistry, Orders of magnitude (mass), Analytical Chemistry, chemistry.chemical_compound, Pharmacokinetics, Hplc ms ms, Tandem Mass Spectrometry, medicine, Humans, Analytical procedures, cardiovascular diseases, Blood Chemical Analysis, Chromatography, High Pressure Liquid, circulatory and respiratory physiology, medicine.drug
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5
المؤلفون: Ariana Tudoroniu, Mihaela Gheorghe, Isabela Tarcomnicu, Simona Rizea Savu, Irina Boaru, Luigi Silvestro
المصدر: Journal of Chromatography B. 877:3159-3168
مصطلحات موضوعية: Clinical Biochemistry, Ion suppression in liquid chromatography–mass spectrometry, Mass spectrometry, Tandem mass spectrometry, Sensitivity and Specificity, Biochemistry, High-performance liquid chromatography, Analytical Chemistry, Matrix (chemical analysis), chemistry.chemical_compound, Drug Stability, Tandem Mass Spectrometry, Humans, Derivatization, Ibandronic Acid, Chromatography, High Pressure Liquid, Chromatography, Bone Density Conservation Agents, Diphosphonates, Reproducibility of Results, Cell Biology, General Medicine, chemistry, Linear Models, Ion trap, Trimethylsilyldiazomethane
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6
المؤلفون: Luigi, Silvestro, Simona Rizea, Savu, Simona Nicoleta, Savu, Ariana, Tudoroniu, Isabela, Tarcomnicu
المصدر: Biomedical chromatography : BMC. 26(5)
مصطلحات موضوعية: Androstadienes, Spectrometry, Mass, Electrospray Ionization, Drug Stability, Tandem Mass Spectrometry, Linear Models, Fluticasone, Humans, Reproducibility of Results, Albuterol, Salmeterol Xinafoate, Sensitivity and Specificity, Chromatography, Liquid
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7
المؤلفون: Adelina Moise, Silviu Savu Ariana Tudoroniu, Adriana Iordachescu, Luigi Silvestro, Simona Rizea Savu
المصدر: Journal of Analytical & Bioanalytical Techniques.
مصطلحات موضوعية: chemistry.chemical_compound, Bioanalysis, Chromatography, chemistry, Pharmacokinetics, business.industry, Metabolite, Drug metabolite, Medicine, Bioequivalence, business, human activities, health care economics and organizations
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::252148c59bd42877faa1c5fde6255aa8
https://doi.org/10.4172/2155-9872.1000069 -
8
المصدر: Journal of Analytical & Bioanalytical Techniques.
مصطلحات موضوعية: Drug, chemistry.chemical_compound, Chromatography, Pharmacokinetics, Chemistry, Metabolite, media_common.quotation_subject, Antithrombotic, Biological fluids, Extremely Helpful, High-performance liquid chromatography, Inductively coupled plasma mass spectrometry, media_common
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::5fdf50c7bf892cb7622db5673ecb8556
https://doi.org/10.4172/2155-9872.1000070