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Sarah J. Schrieber

us food & drug administration (fda)

13H指数
35论文数
1.3K被引数
收录论文 14
发表时间
Evaluating miRNA Sequencing and Integrative Proteomics for Identifying Plasma miRNAs as Potential Pharmacodynamic Biomarkers of IFNβ-1a Biologics
err2025-12-21
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errOAAI
errMehanna, Mai; Chekka, Lakshmi Manasa; Rosenzweig, Barry A.; Samarth, Deepti P.; Mohamed, Esraa G.; Raplee, Isaac; Sullenberger, Catherine; Decker, Erica; Schrieber, Sarah J.; Wang, Yow-Ming; Florian, Jeffry; Hyland, Paula L.
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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
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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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Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary
err2022-12-02
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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
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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
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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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The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation and Individual Variability
err2020-02-12
err8
errOAAI
errXie, Tao; Fang, Hui; Ouyang, Weiming; Angart, Phillip; Chiang, Meng-Jung; Bhirde, Ashwinkumar A.; Sheikh, Faruk; Lynch, Patrick; Shah, Ankit B.; Patil, Sharadrao M.; Chen, Kang; Shen, Meiyu; Agarabi, Cyrus; Donnelly, Raymond P.; Brorson, Kurt; Schrieber, Sarah J.; Howard, Kristina E.; Rogstad, Sarah M.; Frucht, David M.
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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies
err2019-10-31
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errOAAI
errLi, Junyi; Florian, Jeffry; Campbell, Elizabeth; Schrieber, Sarah J.; Bai, Jane P. F.; Weaver, James L.; Hyland, Paula L.; Thway, Theingi M.; Matta, Murali K.; Lankapalli, Rachana H.; Narayanasamy, Suresh; Dancy, Jimena; Zusterzeel, Robbert; Tyson, Jessica Y.; Prentice, Kristin W.; Jackson, Kathryn C.; Patel, Vikram; Rouse, Rodney L.; Wang, Yow-Ming C.; Strauss, David G.
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Considerations for Biologic Product Drug-Drug Interactions: A Regulatory Perspective
err2019-03-07
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PREAI
errSchrieber, Sarah J.; Pfuma-Fletcher, Elimika; Wang, Xiaofei; Wang, Yow-Ming C.; Sagoo, Sharonjit; Madabushi, Rajanikanth; Huang, Shiew-Mei; Zineh, Issam
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Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients
err2018-02-02
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PREAI
errLi, Liang; Ma, Lian; Schrieber, Sarah J.; Rahman, Nam Atiqur; Deisseroth, Albert; Farrell, Ann T.; Wang, Yaning; Sinha, Vikram; Marathe, Anshu
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Exposure-Response Relationship of T-DM1: Insight Into Dose Optimization for Patients With HER2-Positive Metastatic Breast Cancer
err2014-01-31
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PREAI
errWang, J.; Song, P.; Schrieber, S.; Liu, Q.; Xu, Q.; Blumenthal, G.; Kordestani, L. Amiri; Cortazar, P.; Ibrahim, A.; Justice, R.; Wang, Y.; Tang, S.; Booth, B.; Mehrotra, N.; Rahman, A.
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