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Center for Biologics Evaluation & Research (Cber)

Scholars944
Papers608
Citations0
Related Papers (606)
Publication Date
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Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report
errBiologicals
IF1.5
err2026-08-01
err0
errOAAI
errde Moerlooze, Laurence; Allen, Alexander; Bartalesi, Ilaria; Cavaleri, Marco; Davenport, Miles P.; Gessner, Bradford D.; Gomes, Brenda; Hayford, Kyla; Izu, Alane; Izurieta, Hector S.; Jenkins, Victoria A.; Kastner, Randee; Krause, Phil; Nealon, Joshua; Oostvogels, Lidia; Palmu, Arto A.; Read, Robert C.; Saenz, Carla; Smith, Dean K.; Tuboi, Suely; Vandendriessche, Frank; Baay, Marc; Craig, Danielle; Neels, Pieter; Bollaert, Kaatje
errShare
errSave
An Evidence-Based Approach to Covid-19 Vaccination REPLY
errNew England Journal of Medicine
IF78.5
err2026-05-07
err0
PREAI
errPrasad, Vinay; Makary, Martin A.
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errSave
Potential Effects of Prepubertal Exposure to Perfluorooctane Sulfonic Acid on the First Wave of Folliculogenesis in Young CD-1 Mice
errBirth Defects Research
IF1.6
err2026-05-06
err0
PREAI
errPhanavanh, Bounleut; Moore, Jalina; Inselman, Amy; Li, Xiaoqing; Sung, Kyung; Hung, Pei-Hsuan; You, Li; Nakamura, Noriko
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errSave
Efficient and robust generation of functional hematopoietic cells from human pluripotent stem cells in albumin-free conditions
errStem Cells Translational Medicine
IF4.9
err2026-05-01
err0
PREAI
errKim, Byung Woo; Zhang, Linyi; Liu, Mo; Khanal, Supreet; Jeong, Ye Eun; Zheng, Ge; Bhattarai, Nirjal; Ye, Zhaohui
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errSave
Evaluation of stored whole blood cellular components treated with bactericidal peptides at a higher concentration than required to assess the peptide compatibility with product quality
errBlood Transfusion
IF2.3
err2026-05-01
err0
PREAI
errChattagul, Supaksorn; Jackson, Joseph W.; Jana, Sirsendu; Wood, Francine; Alayash, Abdu I.; Wimley, William C.; Atreya, Chintamani D.
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errSave
HSV ICP27 hijacks host splicing factor SRSF3 to regulate pre-mRNA splicing and export for viral gene expression and immune evasion
errPLoS Pathogens
IF4.9
err2026-04-10
err1
PREAI
errTang, Shuang; Patel, Amita; Takeda, Kazuyo; Peden, Keith; Krause, Philip R.
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errSave
Advancing cell and gene therapy: Application of AI/ML in clinical development and patient management
errJournal of Biopharmaceutical Statistics
IF1.2
err2026-03-01
err0
PREAI
errSpeth, Kelly; Sengupta, Sanhita; Shamsuzzaman, Md; Whitmore, James; Li, Daniel; Chiang, Alan Y.; Xu, Zhenzhen; Song, Qinghua
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errSave
Increased dose of H1N1 pandemic influenza vaccine during pregnancy improves immunity in mothers and infants
errmBio
IF4.7
err2026-03-01
err0
PREAI
errKansara, Dhvanir; Kosikova, Martina; Milletich, Patricia L.; Zhou, Jie; Coughlan, Lynda; Zens, Michael S.; Swamy, Geeta; Hoen, Anne G.; Xie, Hang; Ackerman, Margaret E.; Pasetti, Marcela F.
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errSave
Applications of correlative analysis for chemistry, manufacturing and controls in cell and gene therapy
errJournal of Biopharmaceutical Statistics
IF1.2
err2026-02-01
err0
PREAI
errChoi, Sangwook; Chiang, Alan Y.; Cheng, Catherine; Dai, Tianjiao; Yeh, Tzu-Min; Pikounis, Bill
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errSave
Mutations of six amino acid residues in a B domain-deleted blood coagulation factor VIII have a cumulative effect on increasing its secretion
errResearch and Practice in Thrombosis and Haemostasis
IF3.4
err2026-01-01
err0
PREAI
errShi, Bo; Olivares, Philip; Parunov, Leonid A.; Liang, Yideng; Chun, Haarin; Wu, Wells W.; Simhadri, Vijaya L.; Bajgain, Pratima; Jankowski, Wojciech; Krivega, Margarita; Poniatowski, Julia; Del Greco, Elizabeth; Krivega, Ivan; Shestopal, Svetlana A.; Zulfiker, Abu Hasanat Md; Sauna, Zuben E.; Sarafanov, Andrey G.
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errSave
Intra-host GI.1 norovirus evolution is shaped by genetic drift and purifying selection
errVirus Evolution
IF4
err2026-01-01
err1
PREAI
errTohma, Kentaro; Liu, Pengbo; Koelle, Katia; Sablon, Orlando; Pickett, Taylor; Mazo, Ilya; Moe, Christine L.; Parra, Gabriel, I
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errSave
Cross-species blood transcriptional correlates of BCG-mediated protection against tuberculosis include innate and adaptive immune processes
errJCI Insight
IF6.1
err2025-12-22
err0
errOAAI
errBridges, Kate; Awany, Denis; Gela, Anele; Mwambene, Temwa-Dango; Kurtz, Sherry L.; Baker, Richard E.; Elkins, Karen L.; Sassetti, Christopher M.; Scriba, Thomas J.; Lauffenburger, Douglas A.
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errSave
Uncovering position-specific patterns in codon and codon-pair usage in candidate genes associated with blood coagulation diseases
errNAR GENOMICS AND BIOINFORMATICS
IF2.8
err2025-12-01
err0
PREAI
errClement, Nathan J.; Hamasaki-Katagiri, Nobuko; Lin, Brian; Komar, Anton A.; Dicuccio, Michael; Bar, Haim; Kimchi-Sarfaty, Chava
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errSave
Unbiased metagenomic exploration of transfusion-transmitted infections with nanopore sequencing
errTRANSFUSION
IF2
err2025-12-01
err0
PREAI
errRagupathy, Viswanath; Kelley, Kylan; Zhao, Jiangqin; Mazo, Ilya; Hewlett, Indira
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errSave
Risk of neurologic or immune-mediated adverse events after COVID-19 diagnosis in the United States
errPLOS ONE
IF2.6
err2025-11-24
err0
PREAI
errFisher, Shelby S.; Lindaas, Arnstein; Muthuri, Stella G.; Lloyd, Patricia C.; Gruber, Joann F.; Richey, Morgan M.; Lyu, Hai; Cheng, Angela S.; Kowarski, Lisa S.; Mckillop, Mollie M.; Bui, Christine; Clarke, Tainya C.; Beers, Jeffrey; Burrell, Timothy; Duenas, Pablo Freyria; Chen, Yangping; Sheng, Minya; Forshee, Richard A.; Anderson, Steven A.; Chillarige, Yoganand; Anthony, Mary S.; Shoaibi, Azadeh; Layton, J. Bradley
errShare
errSave
FDA's New Plausible Mechanism Pathway
errNEW ENGLAND JOURNAL OF MEDICINE
IF78.5
err2025-11-01
err9
PREAI
errPrasad, Vinay; Makary, Martin A.
errShare
errSave
Prevalence of HIV, HBV, and HCV in United States blood donations, 2015-2023: The transfusion-transmissible infections monitoring system (TTIMS)
errTRANSFUSION
IF2
err2025-10-01
err0
PREAI
errHuseynova, Emilya; Haynes, James; Notari, Edward P.; Custer, Brian; Reik, Rita; Gorlin, Jed; Belov, Artur; Yang, Hong; Dodd, Roger Y.; Stramer, Susan L.
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errSave
Utilization of Machine Learning Approaches for Drug Clearance Prediction and Population Pharmacokinetic Covariate Analysis
errCTS-CLINICAL AND TRANSLATIONAL SCIENCE
IF2.8
err2025-09-18
err0
errOAAI
errRawal, Atul; Ou, Jiayi; Zhu, Hao; Sauna, Zuben; Tegenge, Million A.
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errSave
Evolution of the AGMK1-9T7 GLI1+ progenitor cells to become tumor cells and potentially cancer-stem cells
errADVANCES IN CANCER BIOLOGY-METASTASIS
IF0
err2025-09-01
err0
errOAAI
errLewis, Andrew M.; Foseh, Gideon; Peden, Keith; Akue, Adovi; Kukuruga, Mark; Rotroff, Daniel; Lewis, Gladys; Mazo, Ilya
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errSave
A Highly Sensitive Multiplex Antibody Assay Reduces Window Period for Detection of Babesia microti Infection
errOPEN FORUM INFECTIOUS DISEASES
IF3.8
err2025-06-01
err0
errOAAI
errMeredith, Scott; Puri, Ankit; Majam, Victoria F.; Zheng, Hong; Oakley, Miranda S.; Tonnetti, Laura; Stramer, Susan L.; Kumar, Sanjai
errShare
errSave