Search Results - "Ryan, Anne M."

Biosimilars: Key regulatory considerations and similarity assessment tools by Kirchhoff, Carol F., Wang, Xiao‐Zhuo Michelle, Conlon, Hugh D., Anderson, Scott, Ryan, Anne M., Bose, Arindam

“…A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already…”
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Immunohistochemical Localization of Phosphodiesterase 10A in Multiple Mammalian Species by Coskran, Timothy M, Morton, Daniel, Menniti, Frank S, Adamowicz, Wendy O, Kleiman, Robin J, Ryan, Anne M, Strick, Christine A, Schmidt, Christopher J, Stephenson, Diane T

“…A monoclonal antibody directed against the amino terminal of rat phosphodiesterase 10A (PDE10A) was used to localize PDE10A in multiple central nervous system…”
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Comparison of hepatic transcription profiles of locked ribonucleic acid antisense oligonucleotides: evidence of distinct pathways contributing to non-target mediated toxicity in mice by Kakiuchi-Kiyota, Satoko, Koza-Taylor, Petra H, Mantena, Srinivasa R, Nelms, Linda F, Enayetallah, Ahmed E, Hollingshead, Brett D, Burdick, Andrew D, Reed, Lori A, Warneke, James A, Whiteley, Lawrence O, Ryan, Anne M, Mathialagan, Nagappan

“…Development of LNA gapmers, antisense oligonucleotides used for efficient inhibition of target RNA expression, is limited by non-target mediated hepatotoxicity…”
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Immunohistochemical localization of PDE10A in the rat brain by Seeger, Thomas F, Bartlett, Brenda, Coskran, Timothy M, Culp, Jeffrey S, James, Larry C, Krull, David L, Lanfear, Jerry, Ryan, Anne M, Schmidt, Christopher J, Strick, Christine A, Varghese, Alison H, Williams, Robert D, Wylie, Patricia G, Menniti, Frank S

“…PDE10A is a newly identified cAMP/cGMP phosphodiesterase for which mRNA is highly expressed in the mammalian striatum. In the present study, PDE10A protein and…”
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Evaluation of the utility of popliteal lymph node examination in a cyclophosphamide model of immunotoxicity in the rat by Lapointe, Jean-Martin, Valdez, Reginald A, Ryan, Anne M, Haley, Patrick J

“…The objective of this study was to characterize the variability of rat lymphoid organ weights and morphology following treatment with a known immunotoxicant,…”
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Medical Interpreters in Outpatient Practice by Jacobs, Barb, Ryan, Anne M, Henrichs, Katherine S, Weiss, Barry D

“…This article provides an overview of the federal requirements related to providing interpreter services for non-English-speaking patients in outpatient…”
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Comparisons of the Intraocular Tissue Distribution, Pharmacokinetics, and Safety of 125I-Labeled Full-Length and Fab Antibodies in Rhesus Monkeys Following Intravitreal Administration by Mordenti, Joyce, Cuthbertson, R. Andrew, Ferrara, Napoleone, Thomsen, Karen, Berleau, Lea, Licko, Vojtech, Allen, Philip C., Valverde, Celia R., Meng, Y. Gloria, Fei, David T.W., Fourre, Kathleen M., Ryan, Anne M.

“…Access of recombinant proteins to the retina following intravitreal administration is poorly understood. A study was conducted in male Rhesus monkeys (15 to 28…”
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Morphogenesis of Postmortem Hepatocyte Vacuolation and Liver Weight Increases in Sprague-Dawley Rats by Xiantang Li, Elwell, Michael R., Ryan, Anne M., Ochoa, Ricardo

“…Accurate interpretation of microscopic changes in tissues is critical in hazard identification and risk assessment. To address a possible confounder, the…”
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Effects of exercise training on cardiac function, gene expression, and apoptosis in rats by Jin, H, Yang, R, Li, W, Lu, H, Ryan, A M, Ogasawara, A K, Van Peborgh, J, Paoni, N F

“…This study determined the effects of exercise training on cardiac function, gene expression, and apoptosis. Rats exposed to a regimen of treadmill exercise for…”
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Key considerations in the preclinical development of biosimilars by Bui, Lynne A., Hurst, Susan, Finch, Gregory L., Ingram, Beverly, Jacobs, Ira A., Kirchhoff, Carol F., Ng, Chee-Keng, Ryan, Anne M.

“…•Preclinical data for the development of biosimilars are different from those obtained in the development of the reference biologic.•The principles and…”
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Medical-Legal Partnerships to Enhance Residency Training in Advance Care Planning by Pettit, Jessie M, Ryan, Anne M, Armin, Julie, Weiss, Barry D

“…Only about one-third of adult Americans have completed advance directives for end-of-life care, and primary care physicians report that they are not always…”
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Kidney Pathology and Investigative Nephrotoxicology Strategies Across Species by Frazier, Kendall S., Ryan, Anne M., Peterson, Richard A., Obert, Leslie A.

“…Drug-induced kidney toxicity is a significant contributor to acute kidney injury. Nephrotoxic drugs need to be identified during nonclinical testing to…”
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Preclinical Safety Evaluation of rhuMAbVEGF, an Antiangiogenic Humanized Monoclonal Antibody by Ryan, Anne M., Eppler, Dorothy Bates, Hagler, Kelly E., Bruner, Richard H., Thomford, Peter J., Hall, Robert L., Shopp, George M., O'Neill, Charles A.

“…Recombinant humanized antivascular endothelial growth factor (rhuMAbVEGF) is a monoclonal IgG, antibody that is being developed as an antiangiogenic agent for…”
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Development of a Method for Profiling Protein Interactions with LNA-Modified Antisense Oligonucleotides Using Protein Microarrays by Kakiuchi-Kiyota, Satoko, Whiteley, Lawrence O, Ryan, Anne M, Mathialagan, Nagappan

“…Development of locked nucleic acid (LNA) gapmers, antisense oligonucleotides used for efficient inhibition of target RNA expression, is limited by…”
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Pilot study of impact of medical-legal partnership services on patients' perceived stress and wellbeing by Ryan, Anne M, Kutob, Randa M, Suther, Emily, Hansen, Mark, Sandel, Megan

“…Medical-legal partnerships (MLPs) bring legal services into health care settings to address patients' unmet legal needs. This pilot project examined whether…”
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Nutrient Approach to Prostate Cancer Prevention: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) by Dunn, Barbara K, Richmond, Ellen S, Minasian, Lori M, Ryan, Anne M, Ford, Leslie G

“…The Selenium and Vitamin E Cancer Prevention Trial (SELECT) randomized 35,533 healthy men, >55 yr old (>50 yr if African American), with normal digital rectal…”
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Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280586 and Rituximab (MabThera®) by Ryan, Anne M., Sokolowski, Sharon A., Ng, Chee-Keng, Shirai, Norimitsu, Collinge, Mark, Shen, Amy C., Arrington, Joshua, Radi, Zaher, Cummings, Thomas R., Ploch, Stephen A., Stephenson, Sarah A., Tripathi, Niraj K., Hurst, Susan I., Finch, Gregory L., Leach, Michael W.

“…Comparative nonclinical studies were conducted with the proposed biosimilar PF-05280586 and rituximab-EU (MabThera®). In side-by-side analyses, peptide maps…”
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Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280014 and Trastuzumab (Herceptin®) by Hurst, Susan, Ryan, Anne M., Ng, Chee-Keng, McNally, James M., Lorello, Leslie G., Finch, Gregory L., Leach, Michael W., Ploch, Stephen A., Fohey, Josh A., Smolarek, Teresa A.

“…Background and Objectives Trastuzumab (Herceptin ® ) is a humanized monoclonal antibody (mAb) that binds to the HER2 protein. PF-05280014 is being developed as…”
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GFRα1 Is an Essential Receptor Component for GDNF in the Developing Nervous System and Kidney by Cacalano, Grace, Fariñas, Isabel, Wang, Li-Chong, Hagler, Kelly, Forgie, Alison, Moore, Mark, Armanini, Mark, Phillips, Heidi, Ryan, Anne M, Reichardt, Louis F, Hynes, Mary, Davies, Alun, Rosenthal, Arnon

“…Glial cell line–derived neurotrophic factor (GDNF) is a distant member of the TGFβ protein family that is essential for neuronal survival and renal…”
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FutureTox II: Contemporary Concepts in Toxicology: Pathways to Prediction: In Vitro and In Silico Models for Predictive Toxicology by Elmore, Susan A., Ryan, Anne M., Wood, Charles E., Crabbs, Torrie A., Sills, Robert C.

“…The Society of Toxicology (SOT) held a very successful FutureTox II Contemporary Concepts in Toxicology (CCT) Conference in Chapel Hill, North Carolina, on…”
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