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David G. Strauss

us food & drug administration (fda)

48H指数
285论文数
9.4K被引数
收录论文 88
发表时间
Proteomic Identification of Plasma Biomarkers of Response to IL-5 Inhibitor Biologics in Healthy Subjects血浆中IL-5抑制剂生物制剂应答反应的蛋白质组学鉴定生物标志物
err2025-11-30
err0
errOAAI
errChekka, Lakshmi Manasa S.; Samarth, Deepti P.; Howard, Kristina E.; Guo, Yan; Mohamed, Esraa G.; Decker, Erica; Wheeler, William; Wommack, Joel; Gogain, Joseph; Deering, Jennifer; Schrieber, Sarah J.; Wang, Yow-Ming; Strauss, David G.; Florian, Jeffry; Hyland, Paula L.
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Characterization of Proteomic Pharmacodynamic Biomarkers of IFNβ-1a Biologics to Inform Potential Utility in Biosimilar DevelopmentIFNβ-1a生物制品蛋白质组学药效学生物标志物的表征,以指导生物类似物开发的潜在用途
err2025-07-04
err0
PREAI
errLakshmi Manasa S. Chekka; Deepti P. Samarth; Yan Guo; Esraa G. Mohamed; Erica Decker; Murali K. Matta; Qin Sun; William Wheeler; Carlos Sanabria; Joel Wommack; Joseph Gogain; Sarah J. Schrieber; Jeffry Florian; Yow-Ming Wang; David G. Strauss; Paula L. Hyland
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Generative Artificial Intelligence Platform for Automating Social Media Posts From Urology Journal Articles: A Cross-Sectional Study and Randomized Assessment生成式人工智能平台,用于自动化泌尿学期刊文章中的社交媒体帖子: 一项横断面研究和随机评估
err2024-12-01
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PREAI
errRamacciotti, Lorenzo Storino; Cei, Francesco; Hershenhouse, Jacob S.; Mokhtar, Daniel; Rodler, Severin; Gill, Karanvir; Strauss, David; Medina, Luis G.; Cai, Jie; Abreu, Andre Luis; Desai, Mihir M.; Sotelo, Rene; Gill, Inderbir S.; Cacciamani, Giovanni E.
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Accuracy of left ventricular mechanical dyssynchrony indices for mechanical characteristics of left bundle branch block using cardiovascular magnetic resonance feature tracking基于心血管磁共振特征跟踪的左心室机械不同步指数对左束支传导阻滞力学特征的准确性
err2024-11-22
err0
PREAI
errLoewenstein, Daniel E.; Wieslander, Bjorn; Heiberg, Einar; Axelsson, Jimmy; Klem, Igor; Nijveldt, Robin; Schelbert, Erik B.; Sorensson, Peder; Sigfridsson, Andreas; Strauss, David G.; Kim, Raymond J.; Atwater, Brett D.; Ugander, Martin
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Naloxone for Opioid Overdose: Reply
err2024-02-09
err0
PREAI
errvan Lemmen, Maarten; Florian, Jeffrey; Li, Zhihua; van Velzen, Monique; van Dorp, Eveline; Niesters, Marieke; Sarton, Elise; Olofsen, Erik; van der Schrier, Rutger; Strauss, David G.; Dahan, Albert
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ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC Studies
err2023-10-01
err5
errOAAI
errWu, Wendy W.; Choe, Moran; Johannesen, Lars; Vicente, Jose; Bende, Girish; Stockbridge, Norman L.; Strauss, David G.; Garnett, Christine
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Opioid Overdose: Limitations in Naloxone Reversal of Respiratory Depression and Prevention of Cardiac Arrest
err2023-07-04
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errOAAI
errvan Lemmen, Maarten; Florian, Jeffrey; Li, Zhihua; van Velzen, Monique; van Dorp, Eveline; Niesters, Marieke; Sarton, Elise; Olofsen, Erik; van der Schrier, Rutger; Strauss, David G.; Dahan, Albert
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A Bioanalytical Method for Quantification of N-nitrosodimethylamine (NDMA) in Human Plasma and Urine with Different Meals and following Administration of Ranitidine
err2023-05-01
err6
errOAAI
errDe Palma, Ryan; Patel, Vikram; Florian, Jeffry; Keire, David; Selaya, Daniela; Strauss, David G.; Rouse, Rodney; Matta, Murali K.
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New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science新科学,药物监管和紧急公共卫生问题: FDA应用监管科学部门的工作
err2023-01-19
err11
errOAAI
errChiu, Kimberly; Racz, Rebecca; Burkhart, Keith; Florian, Jeffry; Ford, Kevin; Iveth Garcia, M.; Geiger, Robert M. M.; Howard, Kristina E. E.; Hyland, Paula L. L.; Ismaiel, Omnia A. A.; Kruhlak, Naomi L. L.; Li, Zhihua; Matta, Murali K. K.; Prentice, Kristin W. W.; Shah, Aanchal; Stavitskaya, Lidiya; Volpe, Donna A. A.; Weaver, James L. L.; Wu, Wendy W. W.; Rouse, Rodney; Strauss, David G. G.
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Advancing Innovations in Biosimilars
err2022-12-22
err6
errOAAI
errWang, Yow-Ming; Strauss, David G.
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Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary
err2022-12-02
err5
PREAI
errFlorian, Jeffry; Sun, Qin; Schrieber, Sarah J.; White, Richard; Shubow, Sophie; Johnson-Williams, Bernadette E.; Sheikhy, Morasa; Harrison, Nicholas R.; Parker, Valerie J.; Wang, Yow-Ming; Strauss, David G.
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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products
err2022-12-02
err5
PREAI
errFlorian, Jeffry; Gershuny, Victoria; Sun, Qin; Schrieber, Sarah J.; Matta, Murali K.; Hazel, Anthony; Sheikhy, Morasa; Weaver, James L.; Hyland, Paula L.; Hsiao, Cheng-Hui; Vegesna, Giri; DePalma, Ryan; Shah, Aanchal; Prentice, Kristin; Sanabria, Carlos; Wang, Yow-Ming; Strauss, David G.
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Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics
err2022-11-19
err4
PREAI
errHyland, Paula L. L.; Chekka, Lakshmi Manasa S.; Samarth, Deepti P. P.; Rosenzweig, Barry A. A.; Decker, Erica; Mohamed, Esraa G. G.; Guo, Yan; Matta, Murali K. K.; Sun, Qin; Wheeler, William; Sanabria, Carlos; Weaver, James L.; Schrieber, Sarah J.; Florian, Jeffry; Wang, Yow-Ming; Strauss, David G. G.
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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors
err2022-11-15
err5
PREAI
errSheikhy, Morasa; Schrieber, Sarah J.; Sun, Qin; Gershuny, Victoria; Matta, Murali K.; Bai, Jane P. F.; Du, Xiulian; Vegesna, Giri; Shah, Aanchal; Prentice, Kristin; Nalepinski, Colleen; Zineh, Issam; Wang, Yow-Ming; Strauss, David G.; Florian, Jeffry
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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists
err2022-10-21
err6
PREAI
errGershuny, Victoria; Sun, Qin; Schrieber, Sarah J.; Matta, Murali K.; Weaver, James L.; Ji, Ping; Sheikhy, Morasa; Hsiao, Cheng-Hui; Vegesna, Giri; Shah, Aanchal; Prentice, Kristin; Deering, Jennifer; Wang, Yow-Ming; Strauss, David G.; Florian, Jeffry
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Effect of Paroxetine or Quetiapine Combined With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia A Randomized Clinical Trial帕罗西汀或喹硫平联合羟考酮与单用羟考酮对高碳酸血症通气影响的随机临床试验
err2022-10-11
err17
errOAAI
errFlorian, Jeffry; van der Schrier, Rutger; Gershuny, Victoria; Davis, Michael C.; Wang, Celine; Han, Xiaomei; Burkhart, Keith; Prentice, Kristin; Shah, Aanchal; Racz, Rebecca; Patel, Vikram; Matta, Murali; Ismaiel, Omnia A.; Weaver, James; Boughner, Rodney; Ford, Kevin; Rouse, Rodney; Stone, Marc; Sanabria, Carlos; Dahan, Albert; Strauss, David G.
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Use of Human iPSC-CMs in Nonclinical Regulatory Studies for Cardiac Safety Assessment
err2022-09-13
err32
errOAAI
errYang, Xi; Ribeiro, Alexandre J. S.; Pang, Li; Strauss, David G.
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