نتائج البحث - "Jenifer Vija"

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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

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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Lack of Neuropathological Changes in Rats Administered Tedizolid Phosphate for Nine Months

المؤلفون: Dragomir Draganov, Frederick B. Oleson, Michael J. Schlosser, Ann Radovsky, Mark T. Butt, Jenifer Vija, Hiromi Hosako

المصدر: Antimicrobial Agents and Chemotherapy. 59:475-481

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cfb09bc29a683d64da26174471f5a1fb
https://doi.org/10.1128/aac.03950-14

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Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

المؤلفون: Robert Nicholson, Douglas M. Fast, Saadya Fatmi, Suzanne Martinez, Masood Khan, Dan Mamelak, Pilar Gonzalez, Zhongping John Lin, William Nowatzke, Laura Wright, John Kamerud, Richard LeLacheur, Daniel Tang, Afshin Safavi, Rafiq Islam, Ray Steffen, Ann Levesque, Jake Harman, Roger Hayes, Shane Karnik, Douglas J Turk, Michele Malone, Steve Lowes, Mohammed Bouhajib, Sofi Gagnon-Carignan, Ronald Shoup, Kayode Awaiye, Jennifer Zimmer, John Allinson, Maria Cruz Caturla, Yansheng Liu, Mark Warren, Jenny Lin, Allan Xu, Scott Reuschel, Wei Garofolo, Xinping Fang, Jenifer Vija, James Petrilla, Laura Cojocaru, Marie Rock, Isabelle Dumont, Curtis Sheldon, Dominique Gouty, Andrew Dinan, Yasuhiro Yamashita

المصدر: Bioanalysis. 4:2335-2342

مصطلحات موضوعية: Bioanalysis, business.industry, education, Clinical Biochemistry, Accounting, Drugs stability, Nanotechnology, Biosimilar, General Medicine, Guideline, Analytical Chemistry, Medical Laboratory Technology, Biomarker (medicine), Business, General Pharmacology, Toxicology and Pharmaceutics, Drug industry, Reference standards

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::cc93f9eed5ee8f578fa4dc829825949d
https://doi.org/10.4155/bio.12.213

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8

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC)

المؤلفون: Thais Rocha, Dan Mamelak, Wei Garofolo, John Kamerud, Chris Cox, Alan Breau, Mohammed Bouhajib, Ronald Shoup, Carmen Dilger, Ming Hung Lin, Richard Houghton, Jim Jersey, Chiara Bigogno, Dieter Zimmer, Jenifer Vija, Timothy Sangster, Marc Moussallie, Roger Hayes, Rand Jenkins, Suzanne Martinez, Michele Malone, Rudi Segers, Philippe Couerbe, John Allinson, James Petrilla, Maria Pawula, Pilar Gonzalez, Lois Folguera, Marie Rock, Colin Pattison, Romuald Sable, Daniel Tang, James Truog, Kirk R. Smith, Mark Warren, Ann Levesque, Saadya Fatmi, Yasuhiro Yamashita, Shane Needham, Zhongping John Lin, Dominique Gouty, Mira Doig, Paula Jardieu, Douglas M. Fast, Isabelle Dumont, Richard Lundberg, Stuart Best, William DeMaio, Andrew Dinan, Sofi Gagnon-Carignan, Farhad Sayyarpour, Afshin Safavi, Jenny Lin, Rachel Green, Kayode Awaiye, Curtis Sheldon, Rafiq Islam, Mark Boterman, John Maltas, Masood Bhatti, Jake Harman, Christoph Siethoff, Masood Khan, William Nowatzke, Tammy Harter, Maria Cruz Caturla, Massimo Breda, Fabio Garofolo, Jianine Jonker, Laura Wright, Laura Cojocaru, Robert Nicholson, Christine Schiebl, Allan Xu, Richard LeLacheur, Leonardo de Souza Teixeira, Yansheng Liu, Petra Struwe, Jim Hillier, Theo de Boer, Mike Allen, Shane Karnik, Douglas J Turk, Xinping Fang, Jennifer Zimmer, Scott Reuschel, Steve Lowes, Thomas Zimmermann, Lee Goodwin, Dick Schoutsen, Ray Steffen

المصدر: Bioanalysis. 4(17)

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::236bc0c69dda34b25a6a2b7351a0009b
https://pubmed.ncbi.nlm.nih.gov/23013394

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9

Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis

المصدر: Bioanalysis. 3(12)

مصطلحات موضوعية: Quality Control, Bioanalysis, business.industry, International Cooperation, Clinical Biochemistry, Nanotechnology, Accounting, Sample (statistics), General Medicine, Reference Standards, Chemistry Techniques, Analytical, Analytical Chemistry, Outsourcing, Biopharmaceutics, Medical Laboratory Technology, Drug Stability, General Pharmacology, Toxicology and Pharmaceutics, business

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d0278e655070669af0761a249e1f2b6
https://pubmed.ncbi.nlm.nih.gov/21679026

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