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81
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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 1 - Small Molecules by LCMS)
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Welink, Jan;
Fluhler, Eric;
Hughes, Nicola;
Arnold, Mark;
Garofolo, Fabio;
Bustard, Mark;
Coppola, Laura;
Dhodda, Raj;
Evans, Christopher;
Gleason, Carol;
Haidar, Sam;
Hayes, Roger;
Heinig, Katja;
Katori, Noriko;
Blaye, Olivier Le;
Li, Wenkui;
Liu, Guowen;
Lima Santos, Gustavo Mendes;
Meng, Min;
Nicholson, Bob;
Savoie, Natasha;
Skelly, Michael;
Sojo, Luis;
Tampal, Nilufer;
de Merbel, Nico van;
Verhaeghe, Tom;
Vinter, Stephen;
Wickremsinhe, Enaksha;
Whale, Emma;
Wilson, Amanda;
Witte, Bä
rbel;
Woolf, Eric;
Dutch MEB, Utrecht, The Netherlands;
Pfizer, Pearl River, NY, USA;
Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada;
Bristol-Myers Squibb, Princeton, NJ, USA;
Angelini Pharma, Piazzale della Stazione, snc, 0040 S. Palomba Pomezia (RM), Italy;
Health Canada, Ottawa, ON, Canada;
Apotex, Toronto, ON, Canada;
AbbVie Inc., North Chicago, IL, USA;
GlaxoSmithKline, King of Prussia, PA, USA;
Bristol-Myers Squibb, Tully, NY, USA;
US FDA, Silver Spring, MD, USA;
MPI Research, Mattawan, MI, USA;
F. Hoffmann-La Roche Ltd., Basel, Switzerland;
Japan MHLW-NIHS, Tokyo, Japan;
France ANSM, Saint-Denis, France;
Novartis, East Hanover, NJ, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
Brazil Anvisa, Brasilia, Brazil;
Covance, Salt Lake City, UT, USA;
PPD, Richmond, VA, USA;
CFABS, Montreal, QC, Canada;
US FDA, Silver Spring, MD, USA;
Xenon Pharmaceuticals Inc., Burnaby, BC, Canada;
Health Canada, Ottawa, ON, Canada;
PRA Health Sciences, Assen, The;
(Bioanalysis,
v.7,
2015,
pp.2913-2925)
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82
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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 2 - Hybrid LBA/LCMS and Input from Regulatory Agencies)
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Ackermann, Brad;
Neubert, Hendrik;
Hughes, Nicola;
Garofolo, Fabio;
Abberley, Lee;
Alley, Stephen C;
Brown-Augsburger, Patricia;
Bustard, Mark;
Chen, Lin-zhi;
Heinrich, Julia;
Katori, Noriko;
Kaur, Surinder;
Kirkovsky, Leo;
Laterza, Omar F;
Le Blaye, Olivier;
Lé
vesque, Ann;
Santos, Gustavo Mendes Lima;
Olah, Timothy;
Savoie, Natasha;
Skelly, Michael;
Spitz, Susan;
Szapacs, Matthew;
Tampal, Nilufer;
Wang, Jian;
Welink, Jan;
Wieling, Jaap;
Haidar, Sam;
Vinter, Stephen;
Whale, Emma;
Witte, Bä
rbel;
Eli Lilly & Company, Indianapolis, IN, USA;
Pfizer, Andover, MA, USA;
Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada;
Angelini Pharma, Piazzale della Stazione, snc, 0040 S. Palomba Pomezia (RM), Italy;
GlaxoSmithKline, King of Prussia, PA, USA;
Seattle Genetics, Bothell, WA, USA;
Eli Lilly & Company, Indianapolis, IN, USA;
Health Canada, Ottawa, ON, Canada;
Boehringer Ingelheim, Ridgefield, CT, USA;
Roche Innovation Center Penzberg, pRED Pharmaceutical Sciences, Germany;
Japan MHLW-NIHS, Tokyo, Japan;
Genentech, South San Francisco, CA, USA;
Pfizer, San Diego, CA, USA;
Merck & Co., Inc., Rahway, NJ, USA;
France ANSM, Saint Denis, France;
inVentiv Health Clinical, Quebec City, QC, Canada;
Brazil ANVISA, Brasilia, Brazil;
Bristol-Myers Squibb, Princeton, NJ, USA;
CFABS, Montreal, QC, Canada;
US FDA, Silver Spring, MD, USA;
MedImmune, Gaithersburg, MD, USA;
GlaxoSmithKline, King of Prussia, PA, USA;
US FDA, Silver Spring, MD, USA;
B;
(Bioanalysis,
v.7,
2015,
pp.3019-3034)
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83
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Prognostic factors associated with disability in a cohort of neuromyelitis optica spectrum disorder and MOG-associated disease from a nationwide Portuguese registry
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Moura, Joã
o;
Samõ
es, Raquel;
Sousa, Ana Paula;
Figueiroa, Só
nia;
Mendonç
a, Teresa;
Abreu, Pedro;
Guimarã
es, Joana;
Melo, Claú
dia;
Sousa, Raquel;
Soares, Mafalda;
Correia, Ana Sofia;
Marques, Inê
s Brá
s;
Perdigã
o, Sandra;
Alves, Ivâ
nia;
Felgueiras, Helena;
Nzwalo, Hipó
lito;
Mendes, Irene;
Almeida, Vâ
nia;
Boleixa, Daniela;
Carneiro, Paula;
Neves, Esmeralda;
Silva, Ana Martins;
Sá
, Maria José
;
Santos, Ernestina;
;
(Journal of the neurological sciences,
v.464,
2024,
pp.123176)
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84
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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs ( Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)
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Booth, Brian;
Stevenson, Lauren;
Pillutla, Renuka;
Buonarati, Michael;
Beaver, Chris;
Fraier, Daniela;
Garofolo, Fabio;
Haidar, Sam;
Islam, Rafiq;
James, Christopher;
Kadavil, John;
Kavetska, Olga;
Li, Fumin;
Satterwhite, Christina;
Savoie, Natasha;
Subramaniam, Sriram;
Tampal, Nilufer;
Thway, Theingi;
Woolf, Eric;
Blaye, Olivier Le;
Andisik, Matthew;
Briscoe, Chad;
Cape, Stephanie;
Dasgupta, Arindam;
Fischer, Sally;
Haidar, Sam;
Hayes, Roger;
Kamerud, John;
Lima Santos, Gustavo Mendes;
Nehls, Corey;
Soo, Catherine;
Vinter, Stephen;
Whale, Emma;
Xu, Keyang;
Cho, Seongeun (Julia);
Edmison, Anna;
Kassim, Sean;
Rocha, Thais Correa;
Welink, Jan;
Amur, Shashi;
Bandukwala, Abbas;
Cherry, Elana;
Hopper, Shirley;
Ishii-Watabe, Akiko;
Kirshner, Susan;
Maher, Kevin;
Pedras-Vasconcelos, Joao;
Saito, Yoshiro;
Saunders, Therese Solstad;
Skibeli, Venke;
Verthelyi, Daniela;
Wang, Yow-Ming;
Yan, Haoheng;
US FDA, Silver Spring, MD, USA;
Biogen, Cambridge, MA, USA;
Bristol-Myers Squibb, Princeton, NJ, USA;
Intertek, San Diego, CA, USA;
Syneos Health, Princeton, NJ, USA;
F. Hoffmann-La Roche Ltd, Basel, Switzerland;
Angelini Pharma, Rome, Italy;
US FDA, Silver Spring, MD, USA;
Celerion, Lincoln, NE, USA;
Amgen Research, Thousand Oaks, CA, USA;
US FDA, Silver Spring, MD, USA;
Pfizer, Groton, CT, USA;
PPD, Middleton, WI, USA;
Charles River, Reno, NV, USA;
CFABS, Montreal, QC, Canada;
US FDA, Silver Spring, MD, USA;
US FDA, Silver Spring, MD, USA;
US FDA, Silver Spring, MD, USA;
Merck Research Labs, West Point, PA, USA;
France ANSM, Saint Denis, France;
Regeneron Pharmaceuticals, Tarrytown, NY, USA;
PRA Health Sciences, Lenexa, KS, USA;
Covance, Madison, WI, USA;
US FDA, Silver Spring, MD, USA;
Genentech, South San Francisco, CA, USA;
US FDA, Silver Spring, MD, USA;
ICON, Whitesboro, NY, USA;
Pfizer, Andover, MA, USA;
Brazil ANVISA, Brasilia, Brazil;
PPD, Richmon;
(Bioanalysis,
v.11,
2019,
pp.2099-2132)
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85
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2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 2 - Hybrid LBA/LCMS and Input from Regulatory Agencies)
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Song, An;
Lee, Anita;
Garofolo, Fabio;
Kaur, Surinder;
Duggan, Jeff;
Evans, Christopher;
Palandra, Joe;
Donato, Lorella Di;
Xu, Keyang;
Bauer, Ronald;
Bustard, Mark;
Chen, Linzhi;
Cocea, Laurent;
Croft, Stephanie;
Galliccia, Fabrizio;
Haidar, Sam;
Hughes, Nicola;
Ishii-Watabe, Akiko;
Islam, Rafiqul;
Jones, Barry;
Kadavil, John;
Krantz, Carsten;
Lima Santos, Gustavo Mendes;
Olah, Timothy;
Pedras-Vasconcelos, Joã
o;
Staelens, Ludovicus;
Saito, Yoshiro;
Savoie, Natasha;
Scheibner, Kara;
Spitz, Susan;
Tampal, Nilufer;
Thomas, Eric;
Vinter, Stephen;
Wakelin-Smith, Jason;
Welink, Jan;
Zeng, Jianing;
Zhou, Shaolian;
Genentech, South San Francisco, CA, USA;
Merck & Co., Inc., Rahway, NJ, USA;
Angelini Pharma, Pomezia, RM, Italy;
Genentech, South San Francisco, CA, USA;
Boehringer-Ingelheim, Ridgefield, CT, USA;
GlaxoSmithKline, King of Prussia, PA, USA;
Pfizer, Andover, MA, USA;
Caprion Biosciences, Montreal, QC, Canada;
Genentech, South San Francisco, CA, USA;
Austria AGES, Wien, Austria;
Health Canada, Ottawa, ON, Canada;
Boehringer-Ingelheim, Ridgefield, CT, USA;
Health Canada, Ottawa, ON, Canada;
WHO, Geneva, Switzerland;
Italy AIFA, Rome, Italy;
US FDA, Silver Spring, MD, USA;
Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada;
Japan MHLW-NIHS, Tokyo, Japan;
Celerion, Lincoln, NE, USA;
Q2 Solutions, Ithaca, NY, USA;
US FDA, Silver Spring, MD, USA;
Novartis, Basel, Switzerland;
Brazil ANVISA, Brasilia, Brazil;
Bristol-Myers Squibb, Princeton, NJ, USA;
US FDA, Silver Spring, MD, USA;
UCB Biopharma, Braine L’Alleud, Belgium;
Japan MHLW-NIH;
(Bioanalysis,
v.8,
2016,
pp.2457-2474)
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86
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The Senator Sam Cohen Affair: Soviet Anti-Semitism, the ALP and the 1961 Federal Election
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Mendes, Philip;
;
(Labour history,
v.78,
2000,
pp.179)
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87
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SAM Effects on Riboflavin: A Biomimetic Catalyst for GlucoseOxidation
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Carvalhal, Rafaela Fernanda;
Mendes, Renata Kelly;
Kubota, Lauro Tatsuo;
;
(International journal of electrochemical science,
v.2,
2007,
pp.973-985)
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88
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Clinically Applicable Segmentation of Head and Neck Anatomy for Radiotherapy: Deep Learning Algorithm Development and Validation Study (Preprint)
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Nikolov Stanislav;
Blackwell Sam;
Zverovitch Alexei;
Mendes Ruheena;
Livne Michelle;
De Fauw Jeffrey;
Patel Yojan;
Meyer Clemens;
Askham Harry;
Romera-Paredes Bernadino;
Kelly Christopher;
Karthikesalingam Alan;
Chu Carlton;
Carnell Dawn;
Boon Cheng;
D'
Souza Derek;
Moinuddin Syed Ali;
Garie Bethany;
McQuinlan Yasmin;
Ireland Sarah;
Hampton Kiarna;
Fuller Krystle;
Montgomery Hugh;
Rees Geraint;
Suleyman Mustafa;
Back Trevor;
Hughes Cían Owen;
Ledsam Joseph R;
Ronneberger Olaf;
;
(,
v.,
2020,
)
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89
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2017 White Paper on Recent Issues in Bioanalysis: Aren’t Bmv Guidance/Guidelines ‘ <i>Scientific</i> ’? (Part 1 - LCMS: Small Molecules, Peptides and Small Molecule Biomarkers)
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Welink, Jan;
Yang, Eric;
Hughes, Nicola;
Rago, Brian;
Woolf, Eric;
Sydor, Jens;
Coppola, Laura;
Ackermann, Brad;
Li, Wenkui;
Alley, Stephen C;
Arnold, Mark;
Berger, Isabella;
Briscoe, Chad;
Buonarati, Michael;
Bustard, Mark;
Cancilla, Mark;
Cho, Seongeun (Julia);
Duggan, Jeff;
Fraier, Daniela;
Garofolo, Fabio;
Green, Rachel;
Haidar, Sam;
Hittle, Lucinda;
Ishii-Watabe, Akiko;
Islam, Rafiq;
Jenkins, Rand;
Jones, Barry;
Kadavil, John;
Kassim, Sean;
Kavetska, Olga;
Blaye, Olivier Le;
Lee, Anita;
Liu, Hanlan;
Mehl, John;
Lima Santos, Gustavo Mendes;
Musuku, Adrien;
Ramanathan, Ragu;
Saito, Yoshiro;
Savoie, Natasha;
Summerfield, Scott;
Surapaneni, Sekhar;
Szapacs, Matthew;
Tampal, Nilufer;
Verhaeghe, Tom;
Vinter, Stephen;
Whale, Emma;
EU EMA, London, UK;
GlaxoSmithKline, King of Prussia, PA, USA;
Biopharma Services, Toronto, ON, Canada;
Pfizer, Groton, CT, USA;
Merck Research Labs, West Point, PA, USA;
AbbVie Inc., North Chicago, IL, USA;
Apotex, Toronto, ON, Canada;
Eli Lilly & Company, Indianapolis, IN, USA;
Novartis, East Hanover, NJ, USA;
Seattle Genetics, Bothell, WA, USA;
Covance, West Trenton, NJ, USA;
Austria AGES, Wien, Austria;
PRA Health Sciences, Overland Park, KS, USA;
Intertek, San Diego, CA, USA;
Health Canada, Ottawa, ON, Canada;
Merck Research Labs, West Point, PA, USA;
US FDA, Silver Spring, MD, USA;
IXD Bioanalytics, Southbury, CT, USA (previously Boehringer-Ingelheim, Ridgefield, CT, USA);
F. Hoffmann-La Roche Ltd, Basel, Switzerland;
Angelini Pharma, Pomezia, RM, Italy;
LGC, Cambridge, UK;
US FDA, Silver Spring, MD, USA;
Merck & Co., Rahway, NJ, USA;
Japan MHLW-NIHS, Tokyo, Japan;
Celerion, Lincoln, NE, USA;
PPD, Richmond, VA, USA;
Q2 Solutions, Ithaca, NY, USA;
US FDA;
(Bioanalysis,
v.9,
2017,
pp.1807-1825)
-
90
-
Transforming the Health Research Workforce in Mozambique: Achievements of the Mozambique Institute for Health Education and Research (MIHER) over a 13‑Year Journey
-
Noormahomed, Emí
lia Virgí
nia;
Noormahomed, Sé
rgio;
Cossa, Matchecane;
Joyce, Nicole;
Miambo, Regina Daniel;
Sousa, Irina Mendes;
Nhacupe, Noé
mia;
Mussá
, Tufá
ria;
Sacarlal, Jahit;
Gouveia, Lí
dia;
Ferrã
o, Luí
s Jorge;
Carrilho, Carla;
Ismail, Mamudo;
Smith, Davey;
Martin, Natasha K.;
Goyal, Ravi;
Barrett, Kim E.;
Afonso, Só
nia Santana;
Mandane, Amé
lia;
Saí
de, Alarquia;
Vintuar, Pompí
lio;
Singo, Brí
gida;
Aleixo, Boaventura;
Injage, Luck;
Winzeler, Elizabeth A.;
Correia-de-Sá
, Paulo;
Do Rosá
rio Oliveira Martins, Maria;
Ferrinho, Paulo;
Patel, Sam;
Mocumbi, Ana Olga;
Bickler, Stephen W.;
Benson, Constance A.;
Badaró
, Roberto;
Schooley, Robert T.;
;
(Annals of global health,
v.90,
2024,
pp.78)