총 105건 중 105건 출력
, 10/11 페이지
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91
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2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)
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Neubert, Hendrik;
Song, An;
Lee, Anita;
Wei, Cong;
Duggan, Jeff;
Xu, Keyang;
Woolf, Eric;
Evans, Chris;
Palandra, Joe;
Laterza, Omar;
Amur, Shashi;
Berger, Isabella;
Bustard, Mark;
Cancilla, Mark;
Chen, Shang-Chiung;
Cho, Seongeun (Julia);
Ciccimaro, Eugene;
Cludts, Isabelle;
Cocea, Laurent;
D’Arienzo, Celia;
Danan-Leon, Lieza;
Donato, Lorella Di;
Garofolo, Fabio;
Haidar, Sam;
Ishii-Watabe, Akiko;
Jiang, Hao;
Kadavil, John;
Kassim, Sean;
Kurki, Pekka;
Blaye, Olivier Le;
Liu, Kai;
Mathews, Rod;
Lima Santos, Gustavo Mendes;
Niwa, Makoto;
Pedras-Vasconcelos, Joã
o;
Qian, Mark;
Rago, Brian;
Saad, Ola;
Saito, Yoshiro;
Savoie, Natasha;
Su, Dian;
Szapacs, Matthew;
Tampal, Nilufer;
Vinter, Stephen;
Wang, Jian;
Welink, Jan;
Whale, Emma;
Wilson, Amanda;
Xue, Y-J;
Pfizer, Andover, MA, USA;
Genentech, South San Francisco, CA, USA;
Merck, Kenilworth, NJ, USA;
Vertex Pharmaceuticals, Boston, MA, USA;
JXD Bioanalytics, Southbury, CT, USA (previously Boehringer-Ingelheim, Ridgefield, CT, USA);
Genentech, South San Francisco, CA, USA;
Merck, West Point, PA, USA;
GlaxoSmithKline, King of Prussia, PA, USA;
Pfizer, Andover, MA, USA;
Merck, Kenilworth, NJ, USA;
US FDA, Silver Spring, MD, USA;
Austria AGES, Wien, Austria;
Health Canada, Ottawa, ON, Canada;
Merck, West Point, PA, USA;
Genentech, South San Francisco, CA, USA;
US FDA, Silver Spring, MD, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
UK MHRA-NIBSC, London, UK;
Health Canada, Ottawa, ON, Canada;
Bristol-Myers Squibb, Princeton, NJ, USA;
AbbVie Stemcentrx, South San Francisco, CA, USA;
Caprion BioSciences, Montreal, QC, Canada;
Angelini Pharma, Rome, Italy;
US FDA, Silver Spring, MD, USA;
Japan MHLW-NIHS, Tokyo, Japan;
Bristol-Myers Squibb, Princeton, NJ, USA;
US FDA, S;
(Bioanalysis,
v.9,
2017,
pp.1895-1912)
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92
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2018 White Paper on Recent Issues in Bioanalysis: Focus on Immunogenicity Assays by Hybrid LBA/LCMS and Regulatory Feedback (Part 2 - PK, PD & ADA Assays by Hybrid LBA/LCMS & Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers and Immunogenicity)
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Neubert, Hendrik;
Olah, Timothy;
Lee, Anita;
Fraser, Stephanie;
Dodge, Robert;
Laterza, Omar;
Szapacs, Matthew;
Alley, Stephen C;
Saad, Ola M;
Amur, Shashi;
Chen, Linzhi;
Cherry, Elana;
Cho, Seongeun (Julia);
Cludts, Isabelle;
Di Donato, Lorella;
Edmison, Anna;
Ferrari, Luca;
Garofolo, Fabio;
Haidar, Sam;
Hopper, Shirley;
Hottenstein, Scott;
Ishii-Watabe, Akiko;
Kassim, Sean;
Kurki, Pekka;
Lima Santos, Gustavo Mendes;
Miscoria, Gilles;
Palandra, Joe;
Pedras-Vasconcelos, Joã
o;
Piccoli, Steven;
Rogstad, Sarah;
Saito, Yoshiro;
Savoie, Natasha;
Sikorski, Timothy;
Spitz, Susan;
Staelens, Ludovicus;
Verthelyi, Daniela;
Vinter, Stephen;
Wadhwa, Meenu;
Wang, Yow-Ming;
Welink, Jan;
Weng, Naidong;
Whale, Emma;
Woolf, Eric;
Wu, Jiang;
Yan, Haoheng;
Yu, Hongbin;
Zhou, Shaolian;
Pfizer, Andover, MA, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
Merck, Kenilworth, NJ, USA;
Pfizer, Groton, CT, USA;
Princeton, NJ, USA;
Merck, Kenilworth, NJ, USA;
GlaxoSmithKline, King of Prussia, PA, USA;
Seattle Genetics, Bothell, WA, USA;
Genentech, South San Francisco, CA, USA;
US FDA, Silver Spring, MD, USA;
Boehringer-Ingelheim, Ridgefield, CT, USA;
Health Canada, Ottawa, ON, Canada;
US FDA, Silver Spring, MD, USA;
UK MHRA-NIBSC, London, UK;
Caprion BioSciences, Montreal, QC, Canada;
Health Canada, Ottawa, ON, Canada;
F Hoffmann-La Roche, Basel, Switzerland;
Angelini Pharma, Rome, Italy;
US FDA, Silver Spring, MD, USA;
UK MHRA, London, UK;
GlaxoSmithKline, King of Prussia, PA, USA;
Japan MHLW-NIHS, Kanagawa, Japan;
US FDA, Silver Spring, MD, USA;
Finland Fimea, Helsinki, Finland;
Brazil Anvisa, Brasilia, Brazil;
Sanofi, Montpellier, France;
Pfizer, Andover, MA, USA;
US FDA, Silver Spring, MD, USA;
Neoteric, Princeton, NJ, USA;
US FDA, Silver Spr;
(Bioanalysis,
v.10,
2018,
pp.1897-1917)
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93
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From Secular Religiosity to Cultural Disjunctions: Visions of Post-Traditional Jewishness in the Thought of Paul Mendes-Flohr
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Shonkoff, Sam S. B.;
Richard S. Dinner Center for Jewish Studies, Graduate Theological Union, Berkeley, CA 94709, USA;
(Religions,
v.13,
2022,
pp.127)
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94
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2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( Part 1 -Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)
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Neubert, Hendrik;
Alley, Stephen C;
Lee, Anita;
Jian, Wenying;
Buonarati, Michael;
Edmison, Anna;
Garofolo, Fabio;
Gorovits, Boris;
Haidar, Sam;
Mylott, Bill;
Nouri, Parya;
Qian, Mark;
Vinter, Stephen;
Voelker, Troy;
Welink, Jan;
Wu, Jiang;
Yang, Eric;
Yu, Hongbin;
Evans, Chris;
Summerfield, Scott;
Wang, Jian;
Bateman, Kevin;
Boer, Jason;
Dean, Brian;
Dillen, Lieve;
Faustino, Patrick;
Ferrari, Luca;
Hughes, Nicola;
Luo, Lina;
Olah, Timothy;
Post, Noah;
Spellman, Daniel S.;
Sydor, Jens;
Zhang, Hui;
Zhang, Jenny;
Zhang, Jinhui;
Fandozzi, Christine;
Wilson, Amanda;
Fraier, Daniela;
Beaver, Christopher J.;
Dandamudi, Suman;
Dasgupta, Arindam;
Elliott, Rebecca;
Ji, Allena;
Li, Wenkui;
McGuinness, Michael;
Lima Santos, Gustavo Mendes;
Mirza, Tahseen;
Savoie, Natasha;
Shakleya, Diaa;
Sporring, Sune;
Stojdl, Susan;
Sundman, Phillip;
Tampal, Nilufer;
Woolf, Eric;
Pfizer, Andover, MA, USA;
Seattle Genetics, Bothell, WA, USA;
Merck, Kenilworth, NJ, USA;
Janssen Research & Development, Spring House, PA, USA;
Intertek, San Diego, CA, USA;
Health Canada, Ottawa, ON, Canada;
BRI, Vancouver, BC, Canada;
Pfizer, Andover, MA, USA;
US FDA, Silver Spring, MD, USA;
PPD, Richmond, VA, USA;
Pfizer, Groton, CT, USA;
Takeda Pharmaceuticals International Co., Cambridge, MA, USA;
UK MHRA, London, UK;
Covance, Salt Lake City, UT, USA;
EMA, London, UK;
Takeda Pharmaceuticals International Co., Cambridge, MA, USA;
GlaxoSmithKline, Collegeville, PA, USA;
Boehringer-Ingelheim, Ridgefield, CT, USA;
GlaxoSmithKline, Collegeville, PA, USA;
GlaxoSmithKline, Ware, UK;
Bristol-Myers Squibb, Princeton, NJ, USA;
Merck, West Point, PA, USA;
Incyte, Wilmington, DE, USA;
Genentech, South San Francisco, CA, USA;
Janssen Research & Development, Beerse, Belgium;
US FDA, Silver Spring, MD, USA;
F. Hoffmann-La Roche Ltd, Basel, Switzerland;
Biopharma Servi;
(Bioanalysis,
v.13,
2021,
pp.203-238)
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95
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2018 White Paper on Recent Issues in Bioanalysis: <i>‘A Global Bioanalytical Community Perspective on Last Decade of Incurred Samples Reanalysis (ISR)’</i> (Part 1 - Small Molecule Regulated Bioanalysis, Small Molecule Biomarkers, Peptides & Oligonucleotide Bioanalysis)
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Welink, Jan;
Xu, Yuanxin;
Yang, Eric;
Wilson, Amanda;
Henderson, Neil;
Luo, Lina;
Fraser, Stephanie;
Kavita, Uma;
Musuku, Adrien;
James, Christopher;
Fraier, Daniela;
Zhang, Yan;
Goykhman, Dina;
Summerfield, Scott;
Woolf, Eric;
Verhaeghe, Tom;
Hughes, Nicola;
Behling, Alexander;
Brown, Kirk;
Bulychev, Alex;
Buonarati, Michael;
Cherry, Elana;
Cho, Seongeun (Julia);
Cludts, Isabelle;
Dillen, Lieve;
Dodge, Robert;
Edmison, Anna;
Garofolo, Fabio;
Green, Rachel;
Haidar, Sam;
Hottenstein, Charles;
Ishii-Watabe, Akiko;
Jang, Hyun Gyung;
Ji, Allena;
Jones, Barry;
Kassim, Sean;
Ma, Mark;
Meena,;
Lima Santos, Gustavo Mendes;
Norris, Daniel A;
Owen, Tate;
Piccoli, Steven;
Ramanathan, Ragu;
Rö
hl, Ingo;
Rosenbaum, Anton I;
Saito, Yoshiro;
Sangster, Timothy;
Savoie, Natasha;
Stebbins, Christopher;
Sydor, Jens;
de Merbel, Nico van;
Verthelyi, Daniela;
Vinter, Stephen;
Whale, Emma;
EU EMA, London, UK;
Alnylam Pharmaceuticals, Cambridge, MA, USA;
GlaxoSmithKline, King of Prussia, PA, USA;
AstraZeneca, Cambridge, UK;
AstraZeneca, Gothenburg, Sweden;
Pfizer, Groton, CT, USA;
Pfizer, Groton, CT, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
Pharmascience, Montreal, QC, Canada;
Amgen Research, Thousand Oaks, CA, USA;
F Hoffmann-La Roche Ltd, Basel, Switzerland;
Bristol-Myers Squibb, Princeton, NJ, USA;
Merck Research Labs, West Point, PA, USA;
GlaxoSmithKline, Ware, UK;
Merck Research Labs, West Point, PA, USA;
Janssen Research & Development, Beerse, Belgium;
Biopharma Services, Toronto, ON, Canada;
PPD, Richmond, VA, USA;
Alnylam Pharmaceuticals, Cambridge, MA, USA;
Moderna Therapeutics, Cambridge, MA, USA;
Intertek, San Diego, CA, USA;
Health Canada, Ottawa, ON, CAN;
US FDA, Silver Spring, MD, USA;
UK MHRA-NIBSC, London, UK;
Janssen Research & Development, Beerse, Belgium;
Princeton, NJ, USA;
Health Canada, Ottawa, ON, CAN;
Angelini Pharm;
(Bioanalysis,
v.10,
2018,
pp.1781-1801)
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96
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2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 3 - Lba, Biomarkers and Immunogenicity)
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Richards, Susan;
Amaravadi, Lakshmi;
Pillutla, Renuka;
Birnboeck, Herbert;
Torri, Albert;
Cowan, Kyra J.;
Papadimitriou, Apollon;
Garofolo, Fabio;
Satterwhite, Christina;
Piccoli, Steven;
Wu, Bonnie;
Krinos-Fiorotti, Corinna;
Allinson, John;
Berisha, Flora;
Cocea, Laurent;
Croft, Stephanie;
Fraser, Stephanie;
Galliccia, Fabrizio;
Gorovits, Boris;
Gupta, Swati;
Gupta, Vinita;
Haidar, Sam;
Hottenstein, Charles;
Ishii-Watabe, Akiko;
Jani, Darshana;
Kadavil, John;
Kamerud, John;
Kramer, Daniel;
Litwin, Virginia;
Lima Santos, Gustavo Mendes;
Nelson, Robert;
Ni, Yan;
Pedras-Vasconcelos, Joã
o;
Qiu, Yongchang;
Rhyne, Paul;
Safavi, Afshin;
Saito, Yoshiro;
Savoie, Natasha;
Scheibner, Kara;
Schick, Eginhard;
Siguenza, Patricia Y.;
Smeraglia, John;
Staack, Roland F.;
Subramanyam, Meena;
Sumner, Giane;
Thway, Theingi;
Uhlinger, David;
Ullmann, Martin;
Vitaliti, Alessandra;
Welink, Jan;
Whiting, Chan C.;
Xue, Li;
Zeng, Rong;
Sanofi, Framingham, MA, USA;
Sanofi, Framingham, MA, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland;
Regeneron Pharmaceuticals, Tarrytown, NY, USA;
Genentech, South San Francisco, CA, USA;
Roche Pharma Research and Early Development, Roche Innovation Center, Munich, Germany;
Angelini Pharma, Pomezia, RM, Italy;
Charles River, Reno, NV, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
Janssen R&D, Spring House, PA, USA;
Bioagilytix Labs, Durham, NC, USA;
LGC, Cambridge, UK;
Daiichi Sankyo, Edison, NJ, USA;
Health Canada, Ottawa, ON, Canada;
WHO, Geneva, Switzerland;
Pfizer, Groton, CT, USA;
Italy AIFA, Rome, Italy;
Pfizer, Andover, MA, USA;
Allergan, Irvine, CA, USA;
Genentech, South San Francisco, CA, USA;
US FDA, Silver Spring, MD, USA;
GlaxoSmithKline, Paoli, PA, USA;
Japan MHLW-NIHS, Tokyo, Japan;
Pfizer, Andover, MA, USA;
US FDA, Silver Spring, MD, USA;
Eurofins Bioanaly;
(Bioanalysis,
v.8,
2016,
pp.2475-2496)
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97
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Plant metabolomics: large-scale phytochemistry in the functional genomics era
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Sumner, Lloyd W;
Mendes, Pedro;
Dixon, Richard A;
;
(Phytochemistry,
v.62,
2003,
pp.817-836)
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98
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Child dental neglect and legal protections: a compendium of briefs from policy reviews in 26 countries and a special administrative region of China
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Folá
yan, Morẹ
́
nikẹ
́
Oluwá
tó
yì
n;
Ramos-Gomez, Francisco;
Fatusi, Olawunmi Adedoyin;
Nabil, Nouran;
Lyimo, Germana V.;
Minja, Irene Kida;
Masumo, Ray M.;
Mohamed, Nadia;
Potgieter, Nicoline;
Matanhire, Cleopatra;
Maposa, Pamela;
Akino, Chiedza Runyararo;
Adeniyi, Abiola;
Mohebbi, Simin Z.;
Ellakany, Passent;
Chen, Jieyi;
Amalia, Rosa;
Iandolo, Alfredo;
Peedikayil, Faizal C.;
Aravind, Athira;
Al-Batayneh, Ola B.;
Khader, Yousef S.;
Al-Maweri, Sadeq Ali;
Sabbah, Wael;
Abeldañ
o Zuñ
iga, Roberto Ariel;
Vukovic, Ana;
Jovanovic, Julijana;
Jafar, Ro’aa Mohammed;
Maldupa, Ilze;
Arheiam, Arheiam;
Mendes, Fausto M.;
Uribe, Sergio E.;
Ló
pez Jordi, Marí
a del Carmen;
Villena, Rita S.;
Duangthip, Duangporn;
Sam-Agudu, Nadia A.;
El Tantawi, Maha;
Department of Child Dental Health , Obafemi Awolowo University , Ile-Ife , Nigeria;
Division of Preventive and Restorative Oral Health Sciences , UCLA School of Dentistry , Los Angeles, CA , United States;
Department of Oral and Maxillofacial Surgery , Obafemi Awolowo University , Ile-Ife , Nigeria;
Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry , Alexandria University , Alexandria , Egypt;
Department of Dentistry , Muhimbili National Hospital , Dar es Salaam , Tanzania;
Department of Restorative Dentistry, Muhimbili University of Health and Allied Sciences, Dar es Salaam , Tanzania;
Department of Community Health and Nutrition, Tanzania Food and Nutrition Centre , Dar es Salaam , Tanzania;
Department of Paediatric Dentistry, Faculty of Dentistry;
(Frontiers in oral health,
v.4,
2023,
pp.1211242)
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99
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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs ( Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)
-
Kaur, Surinder;
Alley, Stephen C;
Szapacs, Matt;
Wilson, Amanda;
Ciccimaro, Eugene;
Su, Dian;
Henderson, Neil;
Chen, Linzhi;
Garofolo, Fabio;
Hengel, Shawna;
Jian, Wenying;
Kellie, John F;
Lee, Anita;
Mehl, John;
Palandra, Joe;
Qiu, Haibo;
Savoie, Natasha;
Shakleya, Diaa;
Staelens, Ludovicus;
Sugimoto, Hiroshi;
Sumner, Giane;
Welink, Jan;
Wheller, Robert;
Xue, Y J;
Zeng, Jianing;
Zhang, Jinhui;
Zhou, Huiyu;
Wang, Jian;
Summerfield, Scott;
Kavetska, Olga;
Dillen, Lieve;
Ramanathan, Ragu;
Baratta, Mike;
Dasgupta, Arindam;
Edmison, Anna;
Ferrari, Luca;
Fischer, Sally;
Fraier, Daniela;
Haidar, Sam;
Heermeier, Kathrin;
James, Christopher;
Ji, Allena;
Luo, Lina;
Lima Santos, Gustavo Mendes;
Post, Noah;
Rosenbaum, Anton I;
Sporring, Sune;
Surapaneni, Sekhar;
Vinter, Stephen;
Wan, Katty;
Woolf, Eric;
Kavetska, Olga;
Cho, Seongeun (Julia);
Kossary, Elham;
Prior, Sandra;
Abhari, Mohsen Rajabi;
Soo, Catherine;
Wang, Yow-Ming;
Bandukwala, A;
Genentech;
Seattle Genetics;
Abbvie;
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca;
Bristol-Myers Squibb;
Mersana;
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca;
Boehringer Ingelheim;
BRI - a Frontage Company;
Seattle Genetics;
Janssen Research & Development;
GlaxoSmithKline;
Merck;
GlaxoSmithKline;
Pfizer;
Regeneron;
WRIB;
US FDA;
UCB;
Takeda;
Regeneron;
EU EMA;
LGC;
Bristol-Myers Squibb;
Bristol-Myers Squibb;
US FDA;
BioMarin;
Crinetics;
GlaxoSmithKline;
Pfizer;
Janssen Research & Development;
Vertex;
Takeda;
US FDA;
Health Canada;
F. Hoffmann-La Roche Ltd;
Genentech;
F. Hoffmann-La Roche Ltd;
US FDA;
Sanofi;
Amgen Research;
Sanofi;
Pfizer;
Brazil ANVISA;
Ionis;
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca;
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioP;
(Bioanalysis,
v.14,
2022,
pp.505-580)
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100
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Metabolic profiling of <i>Medicago truncatula</i> cell cultures reveals the effects of biotic and abiotic elicitors on metabolism
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Broeckling, Corey D.;
Huhman, David V.;
Farag, Mohamed A.;
Smith, Joel T.;
May, Gregory D.;
Mendes, Pedro;
Dixon, Richard A.;
Sumner, Lloyd W.;
The Samuel Roberts Noble Foundation, Plant Biology, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA;
The Samuel Roberts Noble Foundation, Plant Biology, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA;
The Samuel Roberts Noble Foundation, Plant Biology, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA;
Southeastern Oklahoma State University, Physical Sciences, Durant, OK 74701, USA;
The Samuel Roberts Noble Foundation, Plant Biology, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA;
Virginia Bioinformatics Institute, Virginia Polytechnic Institute and State University, Blacksburg, VA 24060, USA;
The Samuel Roberts Noble Foundation, Plant Biology, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA;
The Samuel Roberts Noble Foundation, Plant Biology, 2510 Sam Noble Parkway, Ardmore, OK 73401, USA;
(Journal of experimental botany,
v.56,
2005,
pp.323-336)