Search Results - "G. Halpern, Wendy"

Use of Severity Grades to Characterize Histopathologic Changes by Schafer, Kenneth A., Eighmy, John, Fikes, James D., Halpern, Wendy G., Hukkanen, Renee R., Long, Gerald G., Meseck, Emily K., Patrick, Daniel J., Thibodeau, Michael S., Wood, Charles E., Francke, Sabine

“…The severity grade is an important component of a histopathologic diagnosis in a nonclinical toxicity study that helps distinguish treatment-related effects…”
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Postnatal Hepatobiliary and Gastrointestinal Systems Development and Impact on ADME by G. Halpern, Wendy, Kluever, April, Irizarry Rovira, Armando R.

“…Toxicity can result from variable target organ sensitivity and exposure based on postnatal development. Changes in the gastrointestinal tract (GIT) in neonates…”
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Chronic Administration of Belimumab, a BLyS Antagonist, Decreases Tissue and Peripheral Blood B-Lymphocyte Populations in Cynomolgus Monkeys: Pharmacokinetic, Pharmacodynamic, and Toxicologic Effects by Halpern, Wendy G., Lappin, Patrick, Zanardi, Thomas, Cai, Wendy, Corcoran, Marta, Zhong, John, Baker, Kevin P.

“…The tolerability, pharmacodynamic effects, and pharmacokinetics of belimumab (LymphoStat-B) were evaluated in cynomolgus monkeys. Belimumab is a fully human…”
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Repeat-dose and embryo-fetal developmental toxicity of zinpentraxin alfa by Rao, Gautham K, Santagostino, Sara F, Wong, Lisa, Inoue, Ayumi, Arjomandi, Audrey, Yadav, Rajbharan, Halpern, Wendy G

“…Zinpentraxin alfa is a recombinant human pentraxin-2 (PTX-2) developed for the treatment of various fibrotic diseases with the hypothesis that supplementing…”
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Surfactant protein D is a biomarker of influenza‐related pediatric lung injury by Chakrabarti, Arindam, Nguyen, Allen, Newhams, Margaret M., Ohlson, Maikke B., Yang, Xiaoying, Ulufatu, Sheila, Liu, Shannon, Park, Summer, Xu, Min, Jiang, Jenny, Halpern, Wendy G., Anania, Veronica G., McBride, Jacqueline M., Rosenberger, Carrie M., Randolph, Adrienne G.

“…Background Biomarkers that can risk‐stratify children with influenza virus lower respiratory infection may identify patients for targeted intervention. Early…”
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Applying a weight of evidence approach to the evaluation of developmental toxicity of biopharmaceuticals by Rocca, Meredith, Morford, LaRonda L., Blanset, Diann L., Halpern, Wendy G., Cavagnaro, Joy, Bowman, Christopher J.

“…Toxicity studies in pregnant animals are not always necessary for assessing the human risk of developmental toxicity of biopharmaceuticals. The growing…”
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Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity—Evaluation during Drug Development Guidance for Industry by Hukkanen, Renee R., Halpern, Wendy G., Vidal, Justin D.

“…In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled “Testicular Toxicity: Evaluation during Drug Development…”
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In Vivo Assessment of Antibody-Dependent Enhancement of Influenza B Infection by Rao, Gautham K, Prell, Rodney A, Laing, Steven T, Burleson, Stefanie C M, Nguyen, Allen, McBride, Jacqueline M, Zhang, Crystal, Sheinson, Daniel, Halpern, Wendy G

“…Abstract A theoretical safety concern proposed in the influenza literature is that therapeutic antiviral antibodies could have the potential for…”
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Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development by Halpern, Wendy G., Ameri, Mehrdad, Bowman, Christopher J., Elwell, Michael R., Mirsky, Michael L., Oliver, Julian, Regan, Karen S., Remick, Amera K., Sutherland, Vicki L., Thompson, Kary E., Tremblay, Claudine, Yoshida, Midori, Tomlinson, Lindsay

“…Standard components of nonclinical toxicity testing for novel pharmaceuticals include clinical and anatomic pathology, as well as separate evaluation of…”
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Use of Tissue Cross-reactivity Studies in the Development of Antibody-based Biopharmaceuticals: History, Experience, Methodology, and Future Directions by Leach, Michael W., Halpern, Wendy G., Johnson, Carol W., Rojko, Jennifer L., MacLachlan, Tim K., Chan, Curtis M., Galbreath, Elizabeth J., Ndifor, Anthony M., Blanset, Diann L., Polack, Evelyne, Cavagnaro, Joy A.

“…Tissue cross-reactivity (TCR) studies are screening assays recommended for antibody and antibody-like molecules that contain a complementarity-determining…”
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Perspective on a Modified Developmental and Reproductive Toxicity Testing Strategy for Cancer Immunotherapy by Prell, Rodney A., Halpern, Wendy G., Rao, Gautham K.

“…The intent of cancer immunotherapy (CIT) is to generate and enhance T-cell responses against tumors. The tumor microenvironment establishes several inhibitory…”
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Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices by Morford, LaRonda L., Bowman, Christopher J., Blanset, Diann L., Bøgh, Ingrid B., Chellman, Gary J., Halpern, Wendy G., Weinbauer, Gerhard F., Coogan, Timothy P.

“…Evaluation of pharmaceutical agents in children is now conducted earlier in the drug development process. An important consideration for this pediatric use is…”
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The Role of Pathology in Evaluation of Reproductive, Developmental, and Juvenile Toxicity by Bowman, Christopher J, Halpern, Wendy G

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Generation and characterization of LymphoStat‐B, a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator by Baker, Kevin P., Edwards, Bryan M., Main, Sarah H., Choi, Gil H., Wager, Ruth E., Halpern, Wendy G., Lappin, Patrick B., Riccobene, Todd, Abramian, Donara, Sekut, Les, Sturm, Bonnie, Poortman, Carol, Minter, Ralph R., Dobson, Claire L., Williams, Elizabeth, Carmen, Sara, Smith, Rodger, Roschke, Viktor, Hilbert, David M., Vaughan, Tristan J., Albert, Vivian R.

“…Objective To identify and characterize a fully human antibody directed against B lymphocyte stimulator (BLyS), a tumor necrosis factor–related cytokine that…”
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Scientific and Regulatory Policy Committee (SRPC) Points to Consider Review1: Inclusion of Reproductive and Pathology Endpoints for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development by Halpern, Wendy G., Ameri, Mehrdad, Bowman, Christopher J., Elwell, Michael R., Mirsky, Michael L., Oliver, Julian, Regan, Karen S., Remick, Amera K., Sutherland, Vicki L., Thompson, Kary E., Tremblay, Claudine, Yoshida, Midori, Tomlinson, Lindsay

“…Standard components of nonclinical toxicity testing for novel pharmaceuticals include clinical and anatomic pathology, as well as separate evaluation of…”
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