Search Results - "Bourcier, Todd"

Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment by Egan, Amy G, Blind, Eberhard, Dunder, Kristina, de Graeff, Pieter A, Hummer, B. Timothy, Bourcier, Todd, Rosebraugh, Curtis

“…After evaluating a safety signal regarding pancreatitis and pancreatic cancer in patients using incretin-based drugs, the Food and Drug Administration and the…”
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FDA and industry collaboration: Identifying opportunities to further reduce reliance on nonhuman primates for nonclinical safety evaluations by Ackley, David, Birkebak, Joanne, Blumel, Jorg, Bourcier, Todd, de Zafra, Christina, Goodwin, Andrew, Halpern, Wendy, Herzyk, Danuta, Kronenberg, Sven, Mauthe, Robert, Shenton, Jacintha, Shuey, Dana, Wange, Ronald L.

“…The nonhuman primate (NHP) has always been a limited resource for pharmaceutical research with ongoing efforts to conserve. This is due to their inherent…”
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Reduced myocardial ischemia-reperfusion injury in toll-like receptor 4-deficient mice by OYAMA, Jun-Ichi, BLAIS, Charles JR, XIAOLI LIU, MINYING PU, KOBZIK, Lester, KELLY, Ralph A, BOURCIER, Todd

“…Myocardial ischemia and reperfusion-induced tissue injury involve a robust inflammatory response, but the proximal events in reperfusion injury remain…”
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omega-3 fatty acid docosahexaenoate attenuates endothelial cyclooxygenase-2 induction through both NADP(H) oxidase and PKC epsilon inhibition by Massaro, M, Habib, A, Lubrano, L, Del Turco, S, Lazzerini, G, Bourcier, T, Weksler, B.B, De Caterina, R

“…A high intake of the omega-3 fatty acid docosahexaenoate [docosahexaenoic acid (DHA)] has been associated with systemic antiinflammatory effects and…”
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HMG CoA Reductase Inhibitors Reduce Plasminogen Activator Inhibitor-1 Expression by Human Vascular Smooth Muscle and Endothelial Cells by Bourcier, Todd, Libby, Peter

“…ABSTRACTThe clinical benefit of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) may derive from a qualitative, functional change in…”
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ICH S1 prospective evaluation study: weight of evidence approach to predict outcome and value of 2-year rat carcinogenicity studies. A report from the regulatory authorities subgroup by Bourcier, Todd, McGovern, Timothy, Cavaliero, Tania, Ebere, Geoffrey, Nishikawa, Akiyoshi, Nishimura, Jihei, Ogawa, Kumiko, Pasanen, Markku, Vespa, Alisa, Van der Laan, Jan Willem

“…The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) initiated a process in 2012 to revise the S1B…”
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Chlamydial and human heat shock protein 60s activate human vascular endothelium, smooth muscle cells, and macrophages by Kol, A, Bourcier, T, Lichtman, A H, Libby, P

“…Both chlamydial and human heat shock protein 60s (HSP 60), which colocalize in human atheroma, may contribute to inflammation during atherogenesis. We tested…”
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Functional CD40 ligand is expressed on human vascular endothelial cells, smooth muscle cells, and macrophages: implications for CD40-CD40 ligand signaling in atherosclerosis by Mach, François, Schönbeck, Uwe, Sukhova, Galina K., Bourcier, Todd, Bonnefoy, Jean-Yves, Pober, Jordan S., Libby, Peter

“…Increasing evidence supports involvement of inflammation and immunity in atherogenesis. We report here that CD40 ligand (CD40L), an immunoregulatory signaling…”
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CarcSeq detection of lorcaserin-induced clonal expansion of Pik3ca H1047R mutants in rat mammary tissue by Faske, Jennifer B, Myers, Meagan B, Bryant, Matthew, He, Xiaobo, McLellen, Florence, Bourcier, Todd, Parsons, Barbara L

“…Abstract Lorcaserin is a 5-hydroxytryptamine 2C (serotonin) receptor agonist and a nongenotoxic rat carcinogen, which induced mammary tumors in male and female…”
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Regulation of the thrombotic potential of atheroma by Libby, P, Mach, F, Schönbeck, U, Bourcier, T, Aikawa, M

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An FDA/CDER perspective on nonclinical testing strategies: Classical toxicology approaches and new approach methodologies (NAMs) by Avila, Amy M., Bebenek, Ilona, Bonzo, Jessica A., Bourcier, Todd, Davis Bruno, Karen L., Carlson, David B., Dubinion, John, Elayan, Ikram, Harrouk, Wafa, Lee, Shwu-Luan, Mendrick, Donna L., Merrill, Jill C., Peretz, Jackye, Place, Emily, Saulnier, Muriel, Wange, Ronald L., Yao, Jia, Zhao, Dong, Brown, Paul C.

“…Nonclinical testing of human pharmaceuticals is conducted to assess the safety of compounds to be studied in human clinical trials and for marketing of new…”
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Abstract 6017: Exposure-related DNA methylation and gene expression changes in mammary glands of Sprague Dawley rats treated with lorcaserin by Tryndyak, Volodymyr P., Willett, Rose A., Bourcier, Todd, Beland, Frederick A., Pogribny, Igor P.

“…Abstract The development of cancer in humans is caused by irreversible modifications of the genome through genetic or epigenetic alterations resulting in the…”
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Role of TLR-2 in the Activation of Nuclear Factor κB by Oxidative Stress in Cardiac Myocytes by Frantz, Stefan, Kelly, Ralph A., Bourcier, Todd

“…Growing evidence from patients with heart failure and from experimental animal models implicates effectors of innate immunity in the pathogenesis of this…”
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Improving Prediction of Carcinogenicity to Reduce, Refine, and Replace the Use of Experimental Animals by Bourcier, Todd, McGovern, Tim, Stavitskaya, Lidiya, Kruhlak, Naomi, Jacobson-Kram, David

“…Cancer risk assessment of new pharmaceuticals is crucial to protect public health. However, clinical trials lack the duration needed to clearly detect…”
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Improving Carcinogenicity Assessment by Morton, Daniel, Bourcier, Todd, Alden, Carl L.

“…The ICH initiated talks in June 2012 to revise regulatory guidance for carcinogenicity assessment of pharmaceutical products, stimulated in part by a proposal…”
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Mannose-Binding Lectin Is a Regulator of Inflammation That Accompanies Myocardial Ischemia and Reperfusion Injury by Walsh, Mary C, Bourcier, Todd, Takahashi, Kazue, Shi, Lei, Busche, Marc N, Rother, Russell P, Solomon, Scott D, Ezekowitz, R. Alan B, Stahl, Gregory L

“…The mannose-binding lectin (MBL), a circulating pattern recognition molecule, recognizes a wide range of infectious agents with resultant initiation of the…”
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PPAR gamma Activation in Human Endothelial Cells Increases Plasminogen Activator Inhibitor Type-1 Expression: PPAR gamma as a Potential Mediator in Vascular Disease by Marx, Nikolaus, Bourcier, Todd, Sukhova, Galina K, Libby, Peter, Plutzky, Jorge

“…Plasminogen activator inhibitor type-1 (PAI-1) is a major physiological inhibitor of fibrinolysis, with its plasma levels correlating with the risk for…”
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The nuclear factor kappa-B signaling pathway participates in dysregulation of vascular smooth muscle cells in vitro and in human atherosclerosis by Bourcier, T, Sukhova, G, Libby, P

“…In the lesions of atherosclerosis, vascular smooth muscle cells (SMC) display many functions characteristic of cytokine activation that likely contribute…”
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Role of TLR-2 in the Activation of Nuclear Factor κB by Oxidative Stress in Cardiac Myocytes by Stefan Frantz, Ralph A. Kelly, Todd Bourcier

“…Growing evidence from patients with heart failure and from experimental animal models implicates effectors of innate immunity in the pathogenesis of this…”
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883-4 Myocardial ischemia-reperfusion injury is dependent on lectin complement activation by Walsh, Mary C, Bourcier, Todd, Takahashi, Kazue, Shi, Lei, Ezekowitz, Alan, Stahl, Gregory L

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