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1.

Toward Accurate and Robust Liquid Chromatography-Mass Spectrometry-Based Quantification of Antibody Biotherapeutics in Tissues.

An, Bo; Zhang, Ming; Pu, Jie; Qu, Yang; Shen, Shichen; Zhou, Shaolian; Ferrari, Luca; Vazvaei, Faye; Qu, Jun.

Anal Chem; 92(22): 15152-15161, 2020 11 17.

Artículo en Inglés | MEDLINE | ID: mdl-33155467

2.

High-Throughput, Sensitive LC-MS Quantification of Biotherapeutics and Biomarkers Using Antibody-Free, Peptide-Level, Multiple-Mechanism Enrichment via Strategic Regulation of pH and Ionic and Solvent Strengths.

An, Bo; Zhang, Ming; Pu, Jie; Shen, Shichen; Qu, Yang; Chen, Yuan-Ju; Huo, Shihan; Wang, Xue; Polli, Joseph Ryan; Balthasar, Joseph P; Herzog, Denis; Ferrari, Luca; Staack, Roland F; Richter, Wolfgang F; Otteneder, Michael B; Benincosa, Lisa J; Zhou, Shaolian; Vazvaei, Faye; Qu, Jun.

Anal Chem; 91(5): 3475-3483, 2019 03 05.

Artículo en Inglés | MEDLINE | ID: mdl-30712341

3.

Sensitive, High-Throughput, and Robust Trapping-Micro-LC-MS Strategy for the Quantification of Biomarkers and Antibody Biotherapeutics.

Zhang, Ming; An, Bo; Qu, Yang; Shen, Shichen; Fu, Wei; Chen, Yuan-Ju; Wang, Xue; Young, Rebeccah; Canty, John M; Balthasar, Joseph P; Murphy, Keeley; Bhattacharyya, Debadeep; Josephs, Jonathan; Ferrari, Luca; Zhou, Shaolian; Bansal, Surendra; Vazvaei, Faye; Qu, Jun.

Anal Chem; 90(3): 1870-1880, 2018 02 06.

Artículo en Inglés | MEDLINE | ID: mdl-29276835

4.

Investigating the effect of autoinduction in cynomolgus monkeys of a novel anticancer MDM2 antagonist, idasanutlin, and relevance to humans.

Glenn, Kelli J; Yu, Li J; Reddy, Micaela B; Fretland, Adrian J; Parrott, Neil; Hussain, Sazzad; Palacios, Mary; Vazvaei, Faye; Zhi, Jianguo; Tuerck, Dietrich.

Xenobiotica; 46(8): 667-76, 2016 Aug.

Artículo en Inglés | MEDLINE | ID: mdl-26586447

5.

Clinical application of volumetric absorptive microsampling to the gefapixant development program.

Roadcap, Brad; Hussain, Azher; Dreyer, Dan; Carter, Keynu; Dube, Neal; Xu, Yang; Anderson, Melanie; Berthier, Erwin; Vazvaei, Faye; Bateman, Kevin; Woolf, Eric.

Bioanalysis; 12(13): 893-904, 2020 Jul.

Artículo en Inglés | MEDLINE | ID: mdl-32648772

6.

Entrectinib, a TRK/ROS1 inhibitor with anti-CNS tumor activity: differentiation from other inhibitors in its class due to weak interaction with P-glycoprotein.

Fischer, Holger; Ullah, Mohammed; de la Cruz, Cecile C; Hunsaker, Thomas; Senn, Claudia; Wirz, Thomas; Wagner, Björn; Draganov, Dragomir; Vazvaei, Faye; Donzelli, Massimiliano; Paehler, Axel; Merchant, Mark; Yu, Li.

Neuro Oncol; 22(6): 819-829, 2020 06 09.

Artículo en Inglés | MEDLINE | ID: mdl-32383735

7.

AAPS Workshop Report on ICH M10.

Booth, Brian; Vazvaei, Faye; Fluhler, Eric; Myler, Heather; Woolf, Eric.

AAPS J; 22(1): 10, 2019 12 10.

Artículo en Inglés | MEDLINE | ID: mdl-31823177

8.

A single-center, open-label study investigating the excretion balance, pharmacokinetics, metabolism, and absolute bioavailability of a single oral dose of [¹⁴C]-labeled idasanutlin and an intravenous tracer dose of [¹³C]-labeled idasanutlin in a single cohort of patients with solid tumors.

Pápai, Zsuzsanna; Chen, Lin-Chi; Da Costa, Daniel; Blotner, Steven; Vazvaei, Faye; Gleave, Michelle; Jones, Russell; Zhi, Jianguo.

Cancer Chemother Pharmacol; 84(1): 93-103, 2019 07.

Artículo en Inglés | MEDLINE | ID: mdl-31062077

9.

Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib.

Morcos, Peter N; Cleary, Yumi; Sturm-Pellanda, Carolina; Guerini, Elena; Abt, Markus; Donzelli, Massimiliano; Vazvaei, Faye; Balas, Bogdana; Parrott, Neil; Yu, Li.

J Clin Pharmacol; 58(12): 1618-1628, 2018 12.

Artículo en Inglés | MEDLINE | ID: mdl-30052269

10.

Effects of posaconazole (a strong CYP3A4 inhibitor), two new tablet formulations, and food on the pharmacokinetics of idasanutlin, an MDM2 antagonist, in patients with advanced solid tumors.

Nemunaitis, John; Young, Annie; Ejadi, Samuel; Miller, Wilson; Chen, Lin-Chi; Nichols, Gwen; Blotner, Steven; Vazvaei, Faye; Zhi, Jianguo; Razak, Albiruni.

Cancer Chemother Pharmacol; 81(3): 529-537, 2018 03.

Artículo en Inglés | MEDLINE | ID: mdl-29368050

11.

Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?

Hays, Amanda; Amaravadi, Lakshmi; Fernandez-Metzler, Carmen; King, Lindsay; Mathews, Joel; Ni, Yan; Quadrini, Karen; Tinder, Chunyan; Vazvaei, Faye; Zeng, Jianing.

AAPS J; 24(3): 65, 2022 05 05.

Artículo en Inglés | MEDLINE | ID: mdl-35511303

12.

Bioanalytical method validation considerations for LC-MS/MS assays of therapeutic proteins.

Duggan, Jeffrey X; Vazvaei, Faye; Jenkins, Rand.

Bioanalysis; 7(11): 1389-95, 2015.

Artículo en Inglés | MEDLINE | ID: mdl-26110712

13.

Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.

Jenkins, Rand; Duggan, Jeffrey X; Aubry, Anne-Françoise; Zeng, Jianing; Lee, Jean W; Cojocaru, Laura; Dufield, Dawn; Garofolo, Fabio; Kaur, Surinder; Schultz, Gary A; Xu, Keyang; Yang, Ziping; Yu, John; Zhang, Yan J; Vazvaei, Faye.

AAPS J; 17(1): 1-16, 2015 Jan.

Artículo en Inglés | MEDLINE | ID: mdl-25392238

14.

Repeat analysis and incurred sample reanalysis: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team.

Fluhler, Eric; Vazvaei, Faye; Singhal, Puran; Vinck, Petra; Li, Wenkui; Bhatt, Jignesh; de Boer, Theo; Chaudhary, Ajai; Tangiuchi, Masahiro; Rezende, Vinicius; Zhong, Dafang.

AAPS J; 16(6): 1167-74, 2014 Nov.

Artículo en Inglés | MEDLINE | ID: mdl-25135836

15.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Stevenson, Lauren; Amaravadi, Lakshmi; Myler, Heather; Salazar-Fontana, Laura; Gorovits, Boris; Kirshner, Susan; Xue, Li; Garofolo, Fabio; Alley, Stephen C; Thway, Theingi; Joyce, Alison; Bansal, Surendra; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Dumont, Isabelle; Fluhler, Eric; Fraser, Stephanie; Gouty, Dominique; Gupta, Swati; Haidar, Sam; Hayes, Roger; Ingelse, Benno; Ishii-Watabe, Akiko; Kaur, Surinder; King, Lindsay; Laterza, Omar; Leung, Sheldon; Lévesque, Ann; Ma, Mark; Petit-Frere, Corinne; Pillutla, Renuka; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wakelin-Smith, Jason; Wilson, Amanda; Woolf, Eric; Yang, Tong-Yuan.

Bioanalysis; 6(24): 3355-68, 2014.

Artículo en Inglés | MEDLINE | ID: mdl-25534792

16.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

Fluhler, Eric; Hayes, Roger; Garofolo, Fabio; Dumont, Isabelle; Blaye, Olivier Le; Arnold, Mark; Bansal, Surendra; Verhaeghe, Tom; Wilson, Amanda; Stevenson, Lauren; Myler, Heather; Bauer, Ronald; Bergeron, Annik; Bustard, Mark; Cai, Xiao-Yan; Carbone, Mary; Cojocaru, Laura; Desai-Krieger, Daksha; Duggan, Jeff; Haidar, Sam; Ho, Stacy; Ingelse, Benno; Katori, Noriko; Lévesque, Ann; Lowes, Steve; Ma, Mark; Mettke, Katalina; Michon, Josée; Musuku, Adrien; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Spooner, Neil; Stouffer, Bruce; Vazvaei, Faye; Wakelin-Smith, Jason; Wang, Jian; Welink, Jan; Whale, Emma; Woolf, Eric; Xue, Li; Yang, Tong-Yuan.

Bioanalysis; 6(22): 3039-49, 2014.

Artículo en Inglés | MEDLINE | ID: mdl-25496256

17.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Dufield, Dawn; Neubert, Hendrik; Garofolo, Fabio; Kirkovsky, Leo; Stevenson, Lauren; Dumont, Isabelle; Kaur, Surinder; Xu, Keyang; Alley, Stephen C; Szapacs, Matthew; Arnold, Mark; Bansal, Surendra; Haidar, Sam; Welink, Jan; Le Blaye, Olivier; Wakelin-Smith, Jason; Whale, Emma; Ishii-Watabe, Akiko; Bustard, Mark; Katori, Noriko; Amaravadi, Lakshmi; Aubry, Anne-Françoise; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Duggan, Jeff; Fluhler, Eric; Gorovits, Boris; Gupta, Swati; Hayes, Roger; Ho, Stacy; Ingelse, Benno; King, Lindsay; Lévesque, Ann; Lowes, Steve; Ma, Mark; Musuku, Adrien; Myler, Heather; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wilson, Amanda; Woolf, Eric.

Bioanalysis; 6(23): 3237-49, 2014.

Artículo en Inglés | MEDLINE | ID: mdl-25529890

18.

A look back at the incurred sample reanalysis.

Vazvaei, Faye.

Bioanalysis; 10(21): 1711-1713, 2018 Nov 01.

Artículo en Inglés | MEDLINE | ID: mdl-30412679

19.

Incurred sample reproducibility.

Vazvaei, Faye; Timmerman, Philip.

Bioanalysis; 10(21): 1705-1706, 2018 11 01.

Artículo en Inglés | MEDLINE | ID: mdl-30810353

20.

Enrichment of protein therapeutics and biomarkers for LC-MS quantification.

Pu, Jie; An, Bo; Vazvaei, Faye; Qu, Jun.

Bioanalysis; 10(13): 979-982, 2018 07 01.

Artículo en Inglés | MEDLINE | ID: mdl-29972308

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