Search Results - "Mounho, Barbara"

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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Differential hepatocyte toxicity of recombinant Apo2L/TRAIL versions by Lawrence, David, Shahrokh, Zahra, Marsters, Scot, Achilles, Kirsten, Shih, Danny, Mounho, Barbara, Hillan, Kenneth, Totpal, Klara, DeForge, Laura, Schow, Peter, Hooley, Jeffrey, Sherwood, Steve, Pai, Roger, Leung, Susan, Khan, Lolo, Gliniak, Brian, Bussiere, Jeanine, Smith, Craig A, Strom, Stephen S, Kelley, Sean, Fox, Judith A, Thomas, Deborah, Ashkenazi, Avi

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Biosimilars 2.0: Guiding principles for a global "patients first" standard by Miletich, Joseph, Eich, Geoffrey, Grampp, Gustavo, Mounho, Barbara

“…In the European Union, biosimilar products have been approved since 2006 under an abbreviated pathway that leverages their similarity to an existing…”
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Survey results on the use of the tissue cross-reactivity immunohistochemistry assay by Bussiere, Jeanine L., Leach, Michael W., Price, Karen D., Mounho, Barbara J., Lightfoot-Dunn, Ruth

“…A multinational pharmaceutical and biotechnology company survey was conducted to gain a better understanding of the use and value of the tissue…”
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Antitherapeutic antibody-mediated hepatotoxicity of recombinant human Apo2L/TRAIL in the cynomolgus monkey by Zuch de Zafra, Christina L, Ashkenazi, Avi, Darbonne, Walter C, Cheu, Melissa, Totpal, Klara, Ortega, Shirley, Flores, Heather, Walker, Mark D, Kabakoff, Bruce, Lum, Bert L, Mounho-Zamora, Barbara J, Marsters, Scot A, Dybdal, Noël O

“…Apo2L/TRAIL is a member of the tumor necrosis factor superfamily and an important inducer of apoptosis. Recombinant human (rhu) Apo2L/TRAIL has been attractive…”
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The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro by Mounho, Barbara J., Thrall, Brian D.

“…Peroxisome proliferators are a class of nongenotoxic rodent hepatocarcinogens thought to induce tumors by altering the balance between mitosis and apoptosis…”
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Uses and Future Applications of Flow Cytometry in Immunotoxicity Testing by Burchiel, Scott W., Lauer, Fredine T., Gurulé, Debbie, Mounho, Barbara J., Salas, Virginia M.

“…Flow cytometry is an emerging technology that has numerous applications to immunotoxicity testing. The use and development of high-speed single-cell…”
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Pharmacokinetics and safety of a fully human hepatocyte growth factor antibody, AMG 102, in cynomolgus monkeys by KAKKAR, Tarundeep, MA, Mark, YAO ZHUANG, PATTON, Aaron, ZHENG HU, MOUNHO, Barbara

“…AMG 102, a fully human monoclonal antibody that binds to hepatocyte growth factor (HGF), is a potential cancer therapeutic agent because of its ability to…”
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Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: Is 6 months still appropriate? by Clarke, Janet, Hurst, Christopher, Martin, Pauline, Vahle, John, Ponce, Rafael, Mounho, Barbara, Heidel, Shawn, Andrews, Laura, Reynolds, Theresa, Cavagnaro, Joy

“…For chronic use biotechnology-derived pharmaceuticals, toxicity studies of 6 months have generally been accepted for regulatory approval. This review assessed…”
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Global Regulatory Standards for the Approval of Biosimilars by Mounho, Barbara, Phillips, Audrey, Holcombe, Kay, Grampp, Gustavo, Lubiniecki, Tony, Mollerup, Inger, Jones, Carolyn

“…On March 23, 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act, which contains the Biologics Price Competition and…”
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Cytokines: The Good, the Bad, and the Deadly by Ramani, Thulasi, Auletta, Carol S., Weinstock, Daniel, Mounho-Zamora, Barbara, Ryan, Patricia C., Salcedo, Theodora W., Bannish, Gregory

“…Over the past 30 years, the world of pharmaceutical toxicology has seen an explosion in the area of cytokines. An overview of the many aspects of cytokine…”
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The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Antiapoptotic Effects of Peroxisome Proliferators in Vitro by Mounho, Barbara J., Thrall, Brian D.

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The Development of Therapeutic Monoclonal Antibodies: Overview of the Nonclinical Safety Assessment by Lansita, Janice A., Mounho-Zamora, Barbara

“…Monoclonal antibodies (mAbs) represent a class of biotechnology-derived therapeutics for use in the treatment of various disease indications such as oncology,…”
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Abstract SY03-02: Preclinical assessment of JTX-2011, an agonist antibody targeting ICOS, supports evaluation in ICONIC clinical trial by Michaelson, Jennifer S., Harvey, Christopher, Elpek, Kutlu, Duong, Ellen, Shallberg, Lindsey, Wallace, Matthew, Mabry, Robert, Shu, Jenny, Deshpande, Amit, Zi, Tong, Sazinsky, Stephen, Apgar, Joshua, Mounho-Zamora, Barbara, Briskin, Michael, Trehu, Elizabeth, Reeves, Jason, Hirsch, Heather, Sathyanarayanan, Sriram, Law, Deborah

“…Abstract ICOS (the inducible T-cell co-stimulator) is a co-stimulatory molecule expressed on the surface of T cells and a member of the CD28 family, which…”
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An Introduction to the Regulatory and Nonclinical Aspects of the Nonclinical Development of Antibody Drug Conjugates by Lansita, Janice A., Burke, John M., Apgar, Joshua F., Mounho-Zamora, Barbara

“…Antibody drug conjugates (ADCs) are promising therapies currently in development for oncology with unique and challenging regulatory and scientific…”
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Alterations in Human B Cell Calcium Homeostasis by Polycyclic Aromatic Hydrocarbons: Possible Associations with Cytochrome P450 Metabolism and Increased Protein Tyrosine Phosphorylation by Mounho, Barbara J., Burchiel, Scott W.

“…Previous studies performed in this laboratory have shown that certain benzo(a)pyrene (BaP) metabolites, such as benzo(a)pyrene-7,8-dihydrodiol (BaP-7,8-diol)…”
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The Extracellular Signal-Regulated Kinase Pathway Contributes to Mitogenic and Anti-apoptotic Effects of Peroxisome Proliferators In Vitro by Mounho, Barbara J., Thrall, Brian D.

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Concomitant Administration of Bevacizumab, Irinotecan, 5-Fluorouracil, and Leucovorin: Nonclinical Safety and Pharmacokinetics by Gaudreault, Jacques, Shiu, Vanessa, Bricarello, Ann, Christian, Brian J., Zuch, Christina L., Mounho, Barbara

“…Bevacizumab (Avastin) is a humanized monoclonal antibody against vascular endothelial growth factor approved for use in combination with 5-fluorouracil…”
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Depletion of Glutathione by Benzo(a)pyrene Metabolites, Ionomycin, Thapsigargin, and Phorbol Myristate in Human Peripheral Blood Mononuclear Cells by Romero, David L., Mounho, Barbara J., Lauer, Fredine T., Born, Jerry L., Burchiel, Scott W.

“…Previous studies in this laboratory have shown that polycyclic aromatic hydrocarbons (PAHs) alter Ca2+homeostasis and inhibit activation of both B and T…”
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Characterization of Intracellular Calcium Responses Produced by Polycyclic Aromatic Hydrocarbons in Surface Marker-Defined Human Peripheral Blood Mononuclear Cells by Mounho, Barbara J., Davila, Donna R., Burchiel, Scott W.

“…Previous studies have demonstrated that polycyclic aromatic hydrocarbons (PAHs), such as benzo[a]pyrene (BaP) and 7,12-dimethybenz[a]anthracene (DMBA), and…”
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