Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ-1a Biologics
Hyland, Paula L, Chekka, Lakshmi Manasa S, Samarth, Deepti P, Rosenzweig, Barry A, Decker, Erica, Mohamed, Esraa G, Guo, Yan, Matta, Murali K, Sun, Qin, Wheeler, William, Sanabria, Carlos, Weaver, James L, Schrieber, Sarah J, Florian, Jeffry, Wang, Yow-Ming, Strauss, David G
Published in Clinical pharmacology and therapeutics (01.01.2023)
Published in Clinical pharmacology and therapeutics (01.01.2023)
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Journal Article
BLT-Immune Humanized Mice as a Model for Nivolumab-Induced Immune-Mediated Adverse Events: Comparison of the NOG and NOG-EXL Strains
Weaver, James L, Zadrozny, Leah M, Gabrielson, Kathleen, Semple, Kenrick M, Shea, Katherine I, Howard, Kristina E
Published in Toxicological sciences (01.05.2019)
Published in Toxicological sciences (01.05.2019)
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Journal Article
Assessing the immunogenicity risk of salmon calcitonin peptide impurities using in silico and in vitro methods
Roberts, Brian J., Mattei, Aimee E., Howard, Kristina E., Weaver, James L., Liu, Hao, Lelias, Sandra, Martin, William D., Verthelyi, Daniela, Pang, Eric, Edwards, Katie J., De Groot, Anne S.
Published in Frontiers in pharmacology (09.08.2024)
Published in Frontiers in pharmacology (09.08.2024)
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Journal Article
A metagenomic analysis for combination therapy of multiple classes of antibiotics on the prevention of the spread of antibiotic-resistant genes
Igo, Matthew, Xu, Lei, Krishna, Ashok, Stewart, Sharron, Xu, Lin, Li, Zhihua, Weaver, James L., Stone, Heather, Sacks, Leonard, Bensman, Timothy, Florian, Jeffry, Rouse, Rodney, Han, Xiaomei
Published in Gut microbes (18.12.2023)
Published in Gut microbes (18.12.2023)
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Journal Article
Evaluating the potential of gold, silver, and silica nanoparticles to saturate mononuclear phagocytic system tissues under repeat dosing conditions
Weaver, James L, Tobin, Grainne A, Ingle, Taylor, Bancos, Simona, Stevens, David, Rouse, Rodney, Howard, Kristina E, Goodwin, David, Knapton, Alan, Li, Xiaohong, Shea, Katherine, Stewart, Sharron, Xu, Lin, Goering, Peter L, Zhang, Qin, Howard, Paul C, Collins, Jessie, Khan, Saeed, Sung, Kidon, Tyner, Katherine M
Published in Particle and fibre toxicology (17.07.2017)
Published in Particle and fibre toxicology (17.07.2017)
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Journal Article
Evaluation of a Sequential Antibiotic Treatment Regimen of Ampicillin, Ciprofloxacin and Fosfomycin against Escherichia coli CFT073 in the Hollow Fiber Infection Model Compared with Simultaneous Combination Treatment
Krishna, Ashok, Zere, Tesfalem, Mistry, Sabyasachy, Ismaiel, Omnia, Stone, Heather, Sacks, Leonard V, Weaver, James L
Published in Antibiotics (Basel) (26.11.2022)
Published in Antibiotics (Basel) (26.11.2022)
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Journal Article
Effects of sedative psychotropic drugs combined with oxycodone on respiratory depression in the rat
Xu, Lin, Krishna, Ashok, Stewart, Sharron, Shea, Katherine, Racz, Rebecca, Weaver, James L., Volpe, Donna A., Pilli, Nageswara R., Narayanasamy, Suresh, Florian, Jeffry, Patel, Vikram, Matta, Murali K., Stone, Marc B., Zhu, Hao, Davis, Michael C., Strauss, David G., Rouse, Rodney
Published in Clinical and translational science (01.11.2021)
Published in Clinical and translational science (01.11.2021)
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Journal Article
Development and validation of a liquid-chromatography tandem mass spectrometry method to determine in vitro and in vivo histamine release
Chimalakonda, Krishna C., Pang, Eric, Weaver, James L., Howard, Kristina E., Patel, Vikram, Boyne, Michael T.
Published in Journal of pharmaceutical and biomedical analysis (01.01.2015)
Published in Journal of pharmaceutical and biomedical analysis (01.01.2015)
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Journal Article
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations
Zhang, Xinyuan, Yang, Yuching, Grimstein, Manuela, Liu, Guansheng, Kitabi, Eliford, Fan, Jianghong, Wang, Ying‐Hong, Earp, Justin, Weaver, James L., Zhu, Hao, Liu, Jiang, Reynolds, Kellie S., Huang, Shiew‐Mei, Wang, Yaning
Published in CPT: Pharmacometrics & Systems Pharmacology (01.09.2021)
Published in CPT: Pharmacometrics & Systems Pharmacology (01.09.2021)
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Web Resource
New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science
Chiu, Kimberly, Racz, Rebecca, Burkhart, Keith, Florian, Jeffry, Ford, Kevin, Iveth Garcia, M, Geiger, Robert M, Howard, Kristina E, Hyland, Paula L, Ismaiel, Omnia A, Kruhlak, Naomi L, Li, Zhihua, Matta, Murali K, Prentice, Kristin W, Shah, Aanchal, Stavitskaya, Lidiya, Volpe, Donna A, Weaver, James L, Wu, Wendy W, Rouse, Rodney, Strauss, David G
Published in Frontiers in medicine (19.01.2023)
Published in Frontiers in medicine (19.01.2023)
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Journal Article
Evaluation of nanoparticle immunotoxicity
Dobrovolskaia, Marina A, Germolec, Dori R, Weaver, James L
Published in Nature nanotechnology (01.07.2009)
Published in Nature nanotechnology (01.07.2009)
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Journal Article
Calibration and Validation of a Mechanistic COVID-19 Model for Translational Quantitative Systems Pharmacology - A Proof-of-Concept Model Development for Remdesivir
Samieegohar, Mohammadreza, Weaver, James L, Howard, Kristina E, Chaturbedi, Anik, Mann, John, Han, Xiaomei, Zirkle, Joel, Arabidarrehdor, Ghazal, Rouse, Rodney, Florian, Jeffry, Strauss, David G, Li, Zhihua
Published in Clinical pharmacology and therapeutics (01.10.2022)
Published in Clinical pharmacology and therapeutics (01.10.2022)
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Evaluation of a TGN1412 analogue using in vitro assays and two immune humanized mouse models
Yan, Hangyi, Bhagwat, Bhagyashree, Sanden, David, Willingham, Aarron, Tan, Alick, Knapton, Alan D., Weaver, James L., Howard, Kristina E.
Published in Toxicology and applied pharmacology (01.06.2019)
Published in Toxicology and applied pharmacology (01.06.2019)
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Journal Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists
Gershuny, 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
Published in Clinical pharmacology and therapeutics (01.01.2023)
Published in Clinical pharmacology and therapeutics (01.01.2023)
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Effect of drug combinations on the kinetics of antibiotic resistance emergence in Escherichia coli CFT073 using an in vitro hollow-fibre infection model
Garimella, Narayana, Zere, Tesfalem, Hartman, Neil, Gandhi, Adarsh, Bekele, Aschalew, Li, Xianbin, Stone, Heather, Sacks, Leonard, Weaver, James L.
Published in International journal of antimicrobial agents (01.04.2020)
Published in International journal of antimicrobial agents (01.04.2020)
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Journal Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products
Florian, 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
Published in Clinical pharmacology and therapeutics (01.02.2023)
Published in Clinical pharmacology and therapeutics (01.02.2023)
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Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies
Li, 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.
Published in Clinical pharmacology and therapeutics (01.01.2020)
Published in Clinical pharmacology and therapeutics (01.01.2020)
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Scientific and Regulatory Policy Committee Points-to-consider Paper: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides
Engelhardt, Jeffery A, Fant, Pierluigi, Guionaud, Silvia, Henry, Scott P, Leach, Michael W, Louden, Calvert, Scicchitano, Marshall S, Weaver, James L, Zabka, Tanja S, Frazier, Kendall S
Published in Toxicologic pathology (01.10.2015)
Published in Toxicologic pathology (01.10.2015)
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