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, 10/11 페이지

  • 91
    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)
    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)
  • 92
    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)
    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)
  • 93
    From Secular Religiosity to Cultural Disjunctions: Visions of Post-Traditional Jewishness in the Thought of Paul Mendes-Flohr
    Shonkoff, Sam S. B.; Richard S. Dinner Center for Jewish Studies, Graduate Theological Union, Berkeley, CA 94709, USA; (Religions, v.13, 2022, pp.127)
  • 94
    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)
    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)
  • 95
    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)
    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)
  • 96
    2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 3 - Lba, Biomarkers and Immunogenicity)
    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)
  • 97
    Plant metabolomics: large-scale phytochemistry in the functional genomics era
    Sumner, Lloyd W; Mendes, Pedro; Dixon, Richard A; ; (Phytochemistry, v.62, 2003, pp.817-836)
  • 98
    Child dental neglect and legal protections: a compendium of briefs from policy reviews in 26 countries and a special administrative region of China
    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)
  • 99
    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)
  • 100
    Metabolic profiling of <i>Medicago truncatula</i> cell cultures reveals the effects of biotic and abiotic elicitors on metabolism
    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)
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