Search Results - "HALPERN, Wendy"

Physiology of the neonatal gastrointestinal system relevant to the disposition of orally administered medications by Neal-Kluever, April, Fisher, Jeffrey, Grylack, Lawrence, Kakiuchi-Kiyota, Satoko, Halpern, Wendy

“…A thorough knowledge of the newborn (birth to one month postpartum age) infant's gastrointestinal tract (GIT) is critical to the evaluation of the absorption,…”
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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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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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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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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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Phase 1 and Pharmacokinetic Study of Lexatumumab in Patients with Advanced Cancers by PLUMMER, Ruth, ATTARD, Gerhardt, HALPERN, Wendy, COREY, Alfred, CALVERT, Hilary, DE BONO, Johann, PACEY, Simon, LOUISE LI, RAZAK, Albiruni, PERRETT, Rebecca, BARRETT, Mary, JUDSON, Ian, KAYE, Stan, FOX, Norma Lynn

“…Purpose: To assess the safety and tolerability, pharmacokinetics, and early evidence of antitumor activity of escalating doses of lexatumumab (HGS-ETR2), a…”
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Phase I Pharmacokinetic and Biologic Correlative Study of Mapatumumab, a Fully Human Monoclonal Antibody With Agonist Activity to Tumor Necrosis Factor–Related Apoptosis-Inducing Ligand Receptor-1 by TOLCHER, Anthony W, MITA, Monica, HALPERN, Wendy, COREY, Alfred, COHEN, Roger B, MEROPOL, Neal J, VON MEHREN, Margaret, PATNAIK, Amita, PADAVIC, Kristin, HILL, Monique, MAYS, Theresa, MCCOY, Therese, FOX, Norma Lynn

“…To assess the safety, pharmacokinetics, and preliminary evidence of antitumor activity of mapatumumab (HGS-ETR1, TRM-1), a fully human agonist monoclonal…”
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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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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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Atypical presentation and pathogenesis of a macaque lymphocryptoviral‐associated B‐cell lymphoma in a cynomolgus monkey by Adedeji, Adeyemi O., Vemireddi, Vimala, Tripathi, Niraj, Durinck, Steffen, Maher, Jonathan M., Vucic, Domagoj, Halpern, Wendy

“…We report the unique pathogenesis and presentation of a rapidly progressive B‐cell lymphoma in a 3‐year‐old female cynomolgus monkey on day 50 of a 13‐week…”
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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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Albugranin, a recombinant human granulocyte colony stimulating factor (G-CSF) genetically fused to recombinant human albumin induces prolonged myelopoietic effects in mice and monkeys by HALPERN, Wendy, RICCOBENE, Todd A, GRZEGORZEWSKI, Krzysztof J, AGOSTINI, Heidi, BAKER, Kevin, STOLOW, David, GU, Mi-Li, HIRSCH, Jonathan, MAHONEY, Angela, CARRELL, Jeffrey, BOYD, Ernest

“…Albugranin fusion protein is recombinant granulocyte colony stimulating factor (rG-CSF) genetically fused at its N-terminus to the C-terminus of recombinant…”
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Osteostat/Tumor Necrosis Factor Superfamily 18 Inhibits Osteoclastogenesis and Is Selectively Expressed by Vascular Endothelial Cells by Nardelli, Bernardetta, Zaritskaya, Liubov, McAuliffe, William, Ni, Yansong, Lincoln, Clint, Cho, Yun Hee, Birse, Charles E, Halpern, Wendy, Ullrich, Stephen, Moore, Paul A

“…Vascular endothelial cells (EC) participate in the process of bone formation through the production of factors regulating osteoclast differentiation and…”
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Pharmacokinetics and in vitro and in vivo anti-tumor response of an interleukin-2-human serum albumin fusion protein in mice by MELDER, Robert J, OSBORN, Blaire L, GRZEGORZEWSKI, Krzysztof J, GALLANT, Gilles, RICCOBENE, Todd, KANAKARAJ, Palanisamy, PING WEI, GUOXIAN CHEN, STOLOW, David, HALPERN, Wendy Green, MIGONE, Thi-Sau, QI WANG

“…Albuleukin fusion protein is a recombinant human interleukin-2 (rIL-2) genetically fused to recombinant human serum albumin (rHSA). The pharmacokinetics and…”
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