Search Results - "Frazier, Kendall"

Antisense Oligonucleotide Therapies: The Promise and the Challenges from a Toxicologic Pathologist’s Perspective by Frazier, Kendall S.

“…Many antisense oligonucleotides (ASOs) from several classes of molecules are currently in drug development. Despite over 20 years of pharmaceutical research,…”
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Kidney Effects by Alternative Classes of Medicines in Patients and Relationship to Effects in Nonclinical Toxicity Studies by Frazier, Kendall S.

“…Drug-induced kidney injury has historically been associated with renal tubule injury related to small molecule pharmaceuticals such as nonsteroidal…”
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The Impact of Functional and Structural Maturation of the Kidney on Susceptibility to Drug and Chemical Toxicity in Neonatal Rodents by Frazier, Kendall S.

“…Drug responses are often unpredictable in juvenile animal toxicity studies; hence, optimizing dosages is challenging. Renal functional differences based on age…”
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A Review of Specific Biomarkers of Chronic Renal Injury and Their Potential Application in Nonclinical Safety Assessment Studies by Obert, Leslie A., Elmore, Susan A., Ennulat, Daniela, Frazier, Kendall S.

“…A host of novel renal biomarkers have been developed over the past few decades which have enhanced monitoring of renal disease and drug-induced kidney injury…”
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Ontogeny and Cross-species Comparison of Pathways Involved in Drug Absorption, Distribution, Metabolism, and Excretion in Neonates (Review): Kidney by Bueters, Ruud, Bael, An, Gasthuys, Elke, Chen, Connie, Schreuder, Michiel F, Frazier, Kendall S

“…The kidneys play an important role in many processes, including urine formation, water conservation, acid-base equilibrium, and elimination of waste. The…”
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Toxicologic Pathology Forum Opinion Paper: Recommendations for a Tiered Approach to Nonclinical Mechanistic Nephrotoxicity Evaluation by Ennulat, Daniela, Ringenberg, Michael, Frazier, Kendall S.

“…Nephrotoxicity is one of the more common causes of attrition in nonclinical drug development. Like most tissues, the kidney has a limited number of ways of…”
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Drug-induced Glomerulonephritis: The Spectre of Biotherapeutic and Antisense Oligonucleotide Immune Activation in the Kidney by Frazier, Kendall S., Obert, Leslie A.

“…Prevalence of immune-mediated glomerulonephritis has increased in preclinical toxicity studies, with more frequent use of biotherapeutic agents (especially…”
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Proliferative and Nonproliferative Lesions of the Rat and Mouse Urinary System by Frazier, Kendall S., Seely, John Curtis, Hard, Gordon C., Betton, Graham, Burnett, Roger, Nakatsuji, Shunji, Nishikawa, Akiyoshi, Durchfeld-Meyer, Beate, Bube, Axel

“…The INHAND Project (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) is a joint initiative of the Societies of…”
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Drug-induced Physeal Abnormalities in Preclinical Toxicity Studies by Frazier, Kendall S.

“…Most toxic physeal changes are characterized microscopically by altered chondrocyte development, proliferation, or maturation in the growth plate and…”
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Intrarenal Renin–Angiotensin System Involvement in the Pathogenesis of Chronic Progressive Nephropathy—Bridging the Informational Gap Between Disciplines by Obert, Leslie A., Frazier, Kendall S.

“…Chronic progressive nephropathy (CPN) is the most commonly encountered spontaneous background finding in laboratory rodents. Various theories on its…”
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Species Differences in Renal Development and Associated Developmental Nephrotoxicity by Frazier, Kendall S.

“…The developing kidney is sensitive to both morphological and functional disturbances during the gestational and postnatal phases of growth and differentiation…”
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Imaging MS in Toxicology: An Investigation of Juvenile Rat Nephrotoxicity Associated with Dabrafenib Administration by Groseclose, M. Reid, Laffan, Susan B., Frazier, Kendall S., Hughes-Earle, Angela, Castellino, Stephen

“…As part of an investigative nephrotoxicity study, kidney tissues from juvenile rats orally administered dabrafenib at different age intervals between postnatal…”
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Regulatory Forum Opinion Piece: Dispelling Confusing Pathology Terminology: Recognition and Interpretation of Selected Rodent Renal Tubule Lesions by Seely, John Curtis, Frazier, Kendall S.

“…Renal tubule lesions often prove troublesome for toxicologic pathologists because of the diverse nature and interrelated cell types within the kidney and the…”
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Carcinogenicity Assessment of Daprodustat (GSK1278863), a Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase Inhibitor by Adams, David F., Watkins, Mark S., Durette, Luc, Laliberté, Josée, Goulet, Félix, Debien, Elaine, Frazier, Kendall S., Mellal, Nacéra, Chen, Liangfu, Shi, Wei, Thomas, Roberta, Hu, Erding

“…Daprodustat (GSK1278863) is a hypoxia-inducible factor (HIF)-prolyl hydroxylase (PHD) inhibitor in development for treatment of anemia of chronic kidney…”
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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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Renal Papillary Rarefaction: An Artifact Mimicking Papillary Necrosis by Seely, John Curtis, Francke, Sabine, Mog, Steven R., Frazier, Kendall S., Hard, Gordon C.

“…In histopathology, the presence of a tissue change that does not represent the tissue’s normal appearance can often lead to an incorrect diagnosis and…”
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Protein Extraction of Formalin-fixed, Paraffin-embedded Tissue Enables Robust Proteomic Profiles by Mass Spectrometry by Scicchitano, Marshall S, Dalmas, Deidre A, Boyce, Rogely W, Thomas, Heath C, Frazier, Kendall S

“…Global mass spectrometry (MS) profiling and spectral count quantitation are used to identify unique or differentially expressed proteins and can help identify…”
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Species-specific Inflammatory Responses as a Primary Component for the Development of Glomerular Lesions in Mice and Monkeys Following Chronic Administration of a Second-generation Antisense Oligonucleotide by Frazier, Kendall S., Sobry, Cécile, Derr, Victoria, Adams, Mike J., Besten, Cathaline Den, Kimpe, Sjef De, Francis, Ian, Gales, Tracy L., Haworth, Richard, Maguire, Shaun R., Mirabile, Rosanna C., Mullins, David, Palate, Bernard, Doorten, Yolanda Ponstein-Simarro, Ridings, James E., Scicchitano, Marshall S., Silvano, Jérémy, Woodfine, Jennie

“…Chronic administration of drisapersen, a 2′-OMe phosphorothioate antisense oligonucleotide (AON) to mice and monkeys resulted in renal tubular accumulation,…”
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Scientific and Regulatory Policy Committee Points-to-consider Paper: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides by Engelhardt, Jeffery A., Fant, Pierluigi, Guionaud, Silvia, Henry, Scott P., Leach, Michael W., Louden, Calvert, Scicchitano, Marshall S., Weaver, James L., Zabka, Tanja S., Frazier, Kendall S.

“…Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. In recent years, DIVI has been occasionally…”
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Scientific and Regulatory Policy Committee Points-to-consider Paper: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics by Frazier, Kendall S., Engelhardt, Jeffery A., Fant, Pierluigi, Guionaud, Silvia, Henry, Scott P., Leach, Michael W., Louden, Calvert, Scicchitano, Marshall S., Weaver, James L., Zabka, Tanja S.

“…Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. Although DIVI in laboratory animal species has…”
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