Search Results - "Kawabata, Thomas"

The mechanism of action of tofacitinib - an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis by Hodge, Jennifer A, Kawabata, Thomas T, Krishnaswami, Sriram, Clark, James D, Telliez, Jean-Baptiste, Dowty, Martin E, Menon, Sujatha, Lamba, Manisha, Zwillich, Samuel

“…Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease characterised by infiltration of immune cells into the affected synovium, release of…”
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Immunological Responses to Exogenous Insulin by Fineberg, S. Edwin, Kawabata, Thomas T, Finco-Kent, Deborah, Fountaine, Robert J, Finch, Gregory L, Krasner, Alan S

“…Regardless of purity and origin, therapeutic insulins continue to be immunogenic in humans. However, severe immunological complications occur rarely, and less…”
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Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies by Ponce, Rafael, Abad, Leslie, Amaravadi, Lakshmi, Gelzleichter, Thomas, Gore, Elizabeth, Green, James, Gupta, Shalini, Herzyk, Danuta, Hurst, Christopher, Ivens, Inge A., Kawabata, Thomas, Maier, Curtis, Mounho, Barbara, Rup, Bonita, Shankar, Gopi, Smith, Holly, Thomas, Peter, Wierda, Dan

“…An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile…”
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Development of Immunotoxicity Testing Strategies for Immunomodulatory Drugs by Kawabata, Thomas T., Evans, Ellen W.

“…The ICH S8 immunotoxicity testing guideline for human pharmaceuticals was published in 2006 and was intended to provide guidance for assessing the…”
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Characterization of the draining lymph node response in the mouse drug allergy model: A model for drug hypersensitivity reactions by Zhu, Xu, Cole, Susan H, Kawabata, Thomas T, Whritenour, Jessica

“…The mouse drug allergy model (MDAM) was developed as a tool to predict the potential of systemically administered drugs to produce hypersensitivity reactions…”
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Development and partial validation of a mouse model for predicting drug hypersensitivity reactions by Whritenour, Jessica, Cole, Susan, Zhu, Xu, Li, Dingzhou, Kawabata, Thomas T

“…Animal models that can be used to predict the allergenic potential of drug candidates have not been adequately optimized, validated, or characterized. While…”
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Development of a fluorescence-based in vivo phagocytosis assay to measure mononuclear phagocyte system function in the rat by Tartaro, Karrie, VanVolkenburg, Maria, Wilkie, Dean, Coskran, Timothy M, Kreeger, John M, Kawabata, Thomas T, Casinghino, Sandra

“…The mononuclear phagocyte system (MPS) which provides protection against infection is made up of phagocytic cells that engulf and digest bacteria or other…”
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In vitro cytokine release assays for predicting cytokine release syndrome: The current state-of-the-science. Report of a European Medicines Agency Workshop by Vidal, Jean-Marc, Kawabata, Thomas T., Thorpe, Robin, Silva-Lima, Beatriz, Cederbrant, Karin, Poole, Stephen, Mueller-Berghaus, Jan, Pallardy, Marc, Van der Laan, Jan-Willem

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Synthesis and Characterization of Rhenium and Technetium-99m Labeled Insulin by Sundararajan, Chitra, Besanger, Travis R, Labiris, Renee, Guenther, Katharina J, Strack, Thomas, Garafalo, Robert, Kawabata, Thomas T, Finco-Kent, Deborah, Zubieta, Jon, Babich, John W, Valliant, John F

“…A 99mTc-labeled insulin analogue was synthesized through a direct labeling method in which the [99mTc(CO)3]+ core was combined with a protected insulin…”
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Development of a screening assay to evaluate the potential of drugs to cause immune-mediated hypersensitivity reactions by You, Qiang, Cheng, Linling, Li, Dingzhou, Whritenour, Jessica, Kawabata, Thomas T, Ju, Cynthia

“…Evidence suggests that bio-activation of drugs to generate chemically reactive metabolites (RM) that act as haptens to form immunogenic protein conjugates may…”
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Covalent binding of the nitroso metabolite of sulfamethoxazole is important in induction of drug-specific T-cell responses in vivo by Cheng, Linling, Stewart, Benjamin J, You, Qiang, Petersen, Dennis R, Ware, Joseph A, Piccotti, Joseph R, Kawabata, Thomas T, Ju, Cynthia

“…Immune-mediated drug hypersensitivity reactions (IDHRs) represent a significant problem due to their unpredictable and severe nature, as well as the lack of…”
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Assessing the Potential to Induce Respiratory Hypersensitivity by Holsapple, Michael P., Jones, David, Kawabata, Thomas T., Kimber, Ian, Sarlo, Kathy, Selgrade, MaryJane K., Shah, Jui, Woolhiser, Michael R.

“…Acute and repeat dose inhalation studies have been an important part of the safety assessment of drugs, chemicals, and other products throughout the world for…”
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Developmental immunotoxicity (DIT) testing of pharmaceuticals: current practices, state of the science, knowledge gaps, and recommendations by Collinge, Mark, Burns-Naas, Leigh Ann, Chellman, Gary J, Kawabata, Thomas T, Komocsar, Wendy J, Piccotti, Joseph R, Shenton, Jacintha, Wierda, Daniel

“…The development and regulatory approval of immunomodulatory pharmaceuticals to treat many human diseases has increased significantly over the last two decades…”
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Human lymphocyte activation assay: an in vitro method for predictive immunotoxicity testing by Collinge, Mark, Cole, Susan H, Schneider, Patricia A, Donovan, Carol B, Kamperschroer, Cris, Kawabata, Thomas T

“…Preclinical immunotoxicity assessments may be performed during pharmaceutical drug development in order to identify potential cause for concern prior to use in…”
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Measuring T-cell responses against LCV and CMV in cynomolgus macaques using ELISPOT: potential application to non-clinical testing of immunomodulatory therapeutics by Kamperschroer, Cris, O'Donnell, Lynn M, Schneider, Patricia A, Li, Dingzhou, Roy, Marc, Coskran, Timothy M, Kawabata, Thomas T

“…A number of immunomodulatory therapeutics increase the risk of disease associated with latent herpesviruses such as cytomegalovirus (CMV) and Epstein-Barr…”
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Use of an ex vivo local lymph node assay to assess contact hypersensitivity potential by Piccotti, Joseph R, Kawabata, Thomas T

“…The local lymph node assay (LLNA) is used to assess the contact hypersensitivity potential of compounds. In the standard assay, mice are treated topically with…”
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Task force report: Future research needs for the prevention and management of immune-mediated drug hypersensitivity reactions by Adkinson, N.Franklin, Essayan, David, Gruchalla, Rebecca, Haggerty, Helen, Kawabata, Thomas, Sandler, J.David, Updyke, Lawrence, Shear, Neil H., Wierda, Daniel

“…Immune-mediated drug hypersensitivity reactions (IDHR) have a significant impact on clinical practice, drug development, and public health. However, research…”
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Insulin antibodies with pulmonary delivery of insulin by Fineberg, S Edwin, Kawabata, Thomas T, Krasner, Alan S, Fineberg, Naomi S

“…Delivery of insulin to the deep lung presents unique challenges to the body's mucosal defense system. Pulmonary mucosal defense has the ability to discriminate…”
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Herpes Zoster and Tofacitinib Therapy in Patients With Rheumatoid Arthritis by Winthrop, Kevin L., Yamanaka, Hisashi, Valdez, Hernan, Mortensen, Eric, Chew, Robert, Krishnaswami, Sriram, Kawabata, Thomas, Riese, Richard

“…Objective Patients with rheumatoid arthritis (RA) are at increased risk for herpes zoster (HZ) (i.e., shingles). The aim of this study was to determine whether…”
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Urinary corticosterone as an indicator of stress-mediated immunological changes in rats by Pruett, Stephen, Lapointe, Jean-Martin, Reagan, William, Lawton, Michael, Kawabata, Thomas T

“…Drugs that target the CNS or doses of drugs near the maximum tolerated dose may cause a non-specific stress response during routine safety testing in rodents…”
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