Search Results - "McCush, Fred"

Anti-drug Antibody Magnitude and Clinical Relevance Using Signal to Noise (S/N): Bococizumab Case Study by McCush, Fred, Wang, Ellen, Yunis, Carla, Schwartz, Pamela, Baltrukonis, Daniel

“…Historically, the biopharmaceutical industry has used titer to characterize the magnitude of an anti-drug antibody (ADA) response. While reporting levels of…”
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A sensitive LC-MS/MS assay for the determination of dextromethorphan and metabolites in human urine—application for drug interaction studies assessing potential CYP3A and CYP2D6 inhibition by Vengurlekar, Shailesh S, Heitkamp, Jennifer, McCush, Fred, Velagaleti, Poonam R, Brisson, Jerry H, Bramer, Steven L

“…The commonly used antitussive dextromethorphan can be used to simultaneously assess potential cytochrome P450 3A (CYP3A) and CYP2D6 inhibition during drug…”
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Neutralizing Antibody Validation Testing and Reporting Harmonization by Myler, Heather, Pedras-Vasconcelos, João, Lester, Todd, Civoli, Francesca, Xu, Weifeng, Wu, Bonnie, Vainshtein, Inna, Luo, Linlin, Hassanein, Mohamed, Liu, Susana, Ramaswamy, Swarna Suba, Mora, Johanna, Pennucci, Jason, McCush, Fred, Lavelle, Amy, Jani, Darshana, Ambakhutwala, Angela, Baltrukonis, Daniel, Barker, Breann, Carmean, Rebecca, Chung, Shan, Dai, Sheng, DeWall, Stephen, Dholakiya, Sanjay L., Dodge, Robert, Finco, Deborah, Yan, Haoheng, Hays, Amanda, Hu, Zheng, Inzano, Cynthia, Kamen, Lynn, Lai, Ching-Ha, Meyer, Erik, Nelson, Robert, Paudel, Amrit, Phillips, Kelli, Poupart, Marie-Eve, Qu, Qiang, Abhari, Mohsen Rajabi, Ryding, Janka, Sheldon, Curtis, Spriggs, Franklin, Warrino, Dominic, Wu, Yuling, Yang, Lin, Pasas-Farmer, Stephanie

“…Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in…”
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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization by Sumner, Giane, Keller, Steve, Huleatt, James, Staack, Roland F, Wagner, Leslie, Azadeh, Mitra, Bandukwala, Abbas, Cao, Liching, Du, Xiulian, Salinas, Gabriela Franco, Garofolo, Fabio, Harris, Shannon, Hopper, Shirley, Irwin, Chad, Ji, Qin, Joseph, Julie, King, Lindsay, Kinhikar, Arvind, Lu, Yang, Luo, Rosa, Mabrouk, Omar, Malvaux, Ludovic, Marshall, Jean-Claude, McGuire, Kristina, Mikol, Vincent, Neely, Robert, Qiu, Xiazi, Saito, Yoshiro, Salaun, Bruno, Scully, Ingrid, Smeraglia, John, Solstad, Therese, Stoop, Jeroen, Tang, Huaping, Teixeira, Priscila, Wang, Yixin, Wright, Mike, Mendez, Luis, Beaver, Chris, Eacret, Jacqueline, Au-Yeung, Amelia, Decman, Vilma, Dessy, Francis, Eck, Steven, Goihberg, Polina, Alcaide, Enrique Gomez, Gonneau, Christele, Grugan, Katharine, Hedrick, Michael Nathan, Kar, Sumit, Sehra, Sarita, Stevens, Erin, Stevens, Chad, Sun, Yongliang, McCush, Fred, Williams, LaKenya, Fischer, Sally, Wu, Bonnie, Jordan, Gregor, Burns, Chris, Cludts, Isabelle, Coble, Kelly, Grimaldi, Christine, Henderson, Neil, Joyce, Alison, Lotz, Gregor, Lu, Yanmei, Luo, Linlin, Neff, Florian, Sperinde, Gizette, Stubenrauch, Kay-Gunnar, Wang, Yuting, Ware, Mark, Xu, Weifeng

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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunoge by Baratta, Mike, Jian, Wenying, Hengel, Shawna, Kaur, Surinder, Cunliffe, Jennifer, Boer, Jason, Hughes, Nicki, Kar, Sumit, Kellie, John, Kim, Yeoun Jin, Lassman, Michael, Mehl, John, Morgan, Ling, Palandra, Joe, Sarvaiya, Hetal, Zeng, Jianing, Zheng, Naiyu, Wang, Jian, Yuan, Long, Ji, Allena, Kochansky, Christopher, Tao, Lin, Huang, Yue, Maes, Estelle, Barbero, Luca, Contrepois, Kevin, Ferrari, Luca, Fu, Yunlin, Johnson, Jay, Jones, Barry, Kansal, Monika, Lu, Yang, Post, Noah, Shen, Honglue Holly, Xue, Yongjun Y-J, Zhang, Yiyue Cynthia, Biswas, Gopa, Cho, Seongeun Julia, Edmison, Anna, Benson, Kimberly, Abberley, Lee, Azadeh, Mitra, Francis, Jennifer, Garofolo, Fabio, Gupta, Shalini, Ivanova, Iordanka Dany, Ishii-Watabe, Akiko, Karnik, Shane, Kassim, Sean, Kavetska, Olga, Keller, Steve, Kossary, Elham, Li, Wenkui, McCush, Fred, Mendes, Dulcyane Neiva, Abhari, Mohsen Rajabi, Scheibner, Kara, Sikorski, Timothy, Staack, Roland F, Tabler, Edward, Tang, Huaping, Wan, Katty, Wang, Yow-Ming, Whale, Emma, Yang, Li, Zimmer, Jennifer, Bandukwala, Abbas, Du, Xiulian, Kholmanskikh, Olga, Gijsel, Sonja Kwadijk-de, Wadhwa, Meenu, Xu, Joshua, Buoninfante, Alessandra, Cludts, Isabelle, Diebold, Sandra, Maxfield, Kimberly, Mayer, Christian, Pedras-Vasconcelos, Joao, Shubow, Sophie, Tanaka, Yoichi, Tounekti, Omar, Verthelyi, Daniela, Wagner, Leslie

“…The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing…”
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Safety and Pharmacology of a Single Intravenous Dose of Ponezumab in Subjects With Mild-to-Moderate Alzheimer Disease: A Phase I, Randomized, Placebo-Controlled, Double-Blind, Dose-Escalation Study by LANDEN, Jaren W, QINYING ZHAO, KUPIEC, James W, BEDNAR, Martin M, COHEN, Sharon, BORRIE, Michael, WOODWARD, Michael, BILLING, Clare B, BALES, Kelly, ALVEY, Christine, MCCUSH, Fred, YANG, Jerry

“…Ponezumab is a humanized antiamyloid beta (Aβ) monoclonal antibody designed to treat Alzheimer disease (AD). This randomized, double-blind,…”
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Safety and Pharmacology of Ponezumab (PF-04360365) After a Single 10-Minute Intravenous Infusion in Subjects With Mild to Moderate Alzheimer Disease by BURSTEIN, Aaron H, QINYING ZHAO, ROSS, Joel, STYREN, Scot, LANDEN, Jaren W, MA, Wendy W, MCCUSH, Fred, ALVEY, Christine, KUPIEC, James W, BEDNAR, Martin M

“…Ponezumab (PF-04360365) is a humanized anti-amyloid beta (Aβ) monoclonal antibody designed for treatment of Alzheimer disease (AD). A single 2-hour intravenous…”
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