Search Results - "Martin, Pauline L."

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    Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets by Martin, Pauline L, Bugelski, Peter J

    Published in British journal of pharmacology (01-06-2012)
    “…Monoclonal antibodies (mAbs) and fusion proteins directed towards soluble targets make an important contribution to the treatment of disease. The purpose of…”
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    Journal Article
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    Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets by Bugelski, Peter J, Martin, Pauline L

    Published in British journal of pharmacology (01-06-2012)
    “…Monoclonal antibodies (mAbs) and fusion proteins directed towards cell surface targets make an important contribution to the treatment of disease. The purpose…”
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    Journal Article
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    Developmental and reproductive toxicology studies in nonhuman primates by Chellman, Gary J., Bussiere, Jeanine L., Makori, Norbert, Martin, Pauline L., Ooshima, Yojiro, Weinbauer, Gerhard F.

    “…Developmental and reproductive toxicology testing in nonhuman primates (NHPs) has become more common due to the increasing number of biopharmaceuticals in drug…”
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    Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology by Roberts, Stanley A., Andrews, Paul A., Blanset, Diann, Flagella, Kelly M., Gorovits, Boris, Lynch, Carmel M., Martin, Pauline L., Kramer-Stickland, Kimberly, Thibault, Stephane, Warner, Garvin

    Published in Regulatory toxicology and pharmacology (01-12-2013)
    “…•Studies and strategies for design and conduct of ADC nonclinical safety assessment are discussed.•Complexity of ADC’s require a case-by-case…”
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    Journal Article
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    Effects of an Anti-TNF-α Monoclonal Antibody, Administered Throughout Pregnancy and Lactation, on the Development of the Macaque Immune System by Martin, Pauline L., Oneda, Satoru, Treacy, George

    “…Problem  The use of anti‐TNF‐α therapies during pregnancy and lactation on the development of the neonatal immune system has not been fully established. The…”
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    Journal Article
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    Safety Pharmacology of Anticancer Agents by Martin, Pauline L

    “…The safety pharmacology testing for anticancer agents has historically differed for small molecule pharmaceutical drugs versus large-molecule…”
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    Journal Article
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    Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals by Martin, Pauline L., Breslin, William, Rocca, Meredith, Wright, David, Cavagnaro, Joy

    “…This report discusses the principles of developmental and reproductive toxicity (DART) testing for biopharmaceuticals. Biopharmaceuticals are…”
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    Developmental Toxicity Testing of Biopharmaceuticals in Nonhuman Primates: Previous Experience and Future Directions by Martin, Pauline L., Weinbauer, Gerhard F.

    Published in International Journal of Toxicology (01-12-2010)
    “…Developmental toxicity studies for pharmaceutical safety testing are designed to evaluate potential adverse effects of drug treatment on pregnancy and on the…”
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    Book Review Journal Article
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    Placental Transfer of Fc-Containing Biopharmaceuticals across Species, an Industry Survey Analysis by Bowman, Christopher J., Breslin, William J., Connor, Anu V., Martin, Pauline L., Moffat, Graeme J., Sivaraman, Lakshmi, Tornesi, M. Belen, Chivers, Simon

    “…BACKGROUND Understanding species differences in placental transfer of Fc‐containing biopharmaceuticals (particularly monoclonal antibodies) will improve human…”
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    Unexpected Toxicology Findings in Rats Dosed With an Antihuman IL-13 Monoclonal Antibody by Martin, Pauline L., Nnane, Ivo P., Branigan, Patrick, Louden, Calvert

    Published in International journal of toxicology (01-09-2015)
    “…Interleukin 13 (IL-13) is a type 2 helper T cytokine involved in allergic inflammation and immune responses to parasites. CNTO5825 is an antihuman IL-13…”
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    Journal Article
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    Considerations Regarding Nonhuman Primate Use in Safety Assessment of Biopharmaceuticals by Buckley, Lorrene A., Chapman, Kathryn, Burns-Naas, Leigh Ann, Todd, Marque D., Martin, Pauline L., Lansita, Janice A.

    Published in International Journal of Toxicology (01-10-2011)
    “…Selection of a pharmacologically responsive species can represent a major challenge in designing nonclinical safety assessment programs for many…”
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    Book Review Journal Article
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    Effects of CNTO 530, an erythropoietin mimetic-IgG4 fusion protein, on embryofetal development in rats and rabbits by Martin, Pauline L., Sachs, Clifford, Hoberman, Alan, Jiao, Qun, Bugelski, Peter J.

    “…BACKGROUND: CNTO 530is a biopharmaceutical consisting of a novel peptide that mimics the actions of erythropoietin, fused to the Fc fragment of human IgG4…”
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    Journal Article
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    Ocular inflammation in cynomolgus macaques following intravenous administration of a human monoclonal antibody by Martin, Pauline L, Miller, Paul E, Mata, Marielena, Christian, Brian J

    Published in International journal of toxicology (01-01-2009)
    “…Angiogenesis is a major component of the pathogenesis of various ocular diseases, including age-related macular degeneration (AMD). CNTO95 is a fully human…”
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    Journal Article
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    Preclinical Safety and Pharmacology of an Anti-Human Interleukin-13 Monoclonal Antibody in Normal Macaques and in Macaques with Allergic Asthma by Martin, Pauline L., Fisher, Dusti, Glass, William, O’Neil, Karyn, Das, Anuk, Martin, Elise C., Li, Li

    Published in International journal of toxicology (01-09-2008)
    “…Interleukin-13 (IL-13) plays a central role in chronic airway diseases, including asthma. These studies were conducted to evaluate the safety of administration…”
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    Journal Article
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    Increases in adipose and total body weight, but not in lean body mass, associated with subcutaneous administration of Sonic hedgehog-Ig fusion protein to mice by Martin, Pauline L., Lane, Joan, Pouliot, Louise, Gains, Malcolm, Stejskal, Rudolph, Smith, Susan Yvonne, Galdes, Alphonse, Green, James

    Published in Drug development research (01-11-2002)
    “…Sonic hedgehog (Shh) is a member of a family of proteins that are involved in embryonic development. The receptor signaling pathways for Shh persist in adults…”
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    Journal Article
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    Pharmacology and placental transfer of a human αv integrin monoclonal antibody in rabbits by Martin, Pauline L., Zhou, Zhao, Van den Bulck, Kathleen, Kwok, Deborah, Powers, Gordon, Jiao, Qun, Schantz, Allen, Treacy, George

    “…BACKGROUND: Intetumumab is a human IgG1 anti‐αv‐integrin monoclonal antibody that inhibits angiogenesis. Integrin binding and angiogenesis are important in…”
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