Search Results - "translational science"

Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals by Hayase Hakariya, Frank Moriarty, Akihiko Ozaki, Shai Mulinari, Hiroaki Saito, Tetsuya Tanimoto

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Supplementation with omega‐3 or omega‐6 fatty acids attenuates platelet reactivity in postmenopausal women by Adriana Yamaguchi, Livia Stanger, John Cody Freedman, Amanda Prieur, Rachel Thav, Jennyfer Tena, Theodore R. Holman, Michael Holinstat

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Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers by Philipp Badorrek, Claudia Diefenbach, Harald Kögler, Anastasia Eleftheraki, Friedeborg Seitz, Jens M. Hohlfeld

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Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria by Yulan Qi, Gina Patel, Joshua Henshaw, Soumi Gupta, Joy Olbertz, Kevin Larimore, Cary O. Harding, Markus Merilainen, Roberto Zori, Nicola Longo, Barbara K. Burton, Mingjin Li, Zhonghua Gu, Stephen J. Zoog, Haoling H. Weng, Becky Schweighardt

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First‐in‐human study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALPN‐101, a dual CD28/ICOS antagonist, in healthy adult subjects by Jing Yang, Jason D. Lickliter, Jan L. Hillson, Gary D. Means, Russell J. Sanderson, Kay Carley, Almudena Tercero, Kristi L. Manjarrez, Jennifer R. Wiley, Stanford L. Peng

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Longitudinal estimated glomerular filtration rate (eGFR) modeling in long‐term renal function to inform clinical trial design in kidney transplantation by Luke Kosinski, Eric Frey, Amanda Klein, Inish O'Doherty, Klaus Romero, Mark Stegall, Ilkka Helanterä, Ahmed Osama Gaber, William E. Fitzsimmons, Varun Aggarwal, Transplant Therapeutics Consortium (TTC)

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Limited sampling strategies for estimation of tacrolimus exposure in kidney transplant recipients receiving extended‐release tacrolimus preparation by Toqa El‐Nahhas, Joyce Popoola, Iain MacPhee, Atholl Johnston

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SLCO1B1 *15 allele is associated with methotrexate‐induced nausea in pediatric patients with inflammatory bowel disease by Rishi S. Mehta, Zachary L. Taylor, Lisa J. Martin, Michael J. Rosen, Laura B. Ramsey

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Identification of BAG2 and Cathepsin D as Plasma Biomarkers for Parkinson's Disease by Juhee Kang, Jae Whan Kim, Hansol Heo, Jihyun Lee, Kwan Yong Park, Jung Han Yoon, Jaerak Chang

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Performance Index for Types of Clinical Research Support Service Providers for Academic Research Organizations in Japan: A Cross‐Sectional Survey by Keiko Ueda, Naoto Uemura, Kotone Matsuyama, Yuji Nishizaki, Nanae Tanemura, Kento Asano, Yuki Otsuka, Naotake Yanagisawa, Toshiaki Otsuka, Shinji Yasuno, Rieko Ueda, Yumiko Seo, Hironori Nakagami, Shoji Sanada

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CYP2B6 Genotype‐Dependent Inhibition of CYP1A2 and Induction of CYP2A6 by the Antiretroviral Drug Efavirenz in Healthy Volunteers by Ingrid F. Metzger, Nimita Dave, Yvonne Kreutz, Jessica B.L. Lu, Raymond E. Galinsky, Zeruesenay Desta

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Reduced hepatic impairment study to evaluate pharmacokinetics and safety of zavegepant and to inform dosing recommendation for hepatic impairment by Rajinder Bhardwaj, Mary K. Donohue, Jennifer Madonia, Beth Morris, Thomas C. Marbury, Kyle T. Matschke, Robert Croop, Richard Bertz, Jing Liu

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Liquid Biopsy of Bile based on Targeted Mass Spectrometry for the Diagnosis of Malignant Biliary Strictures by Annie Adrait, Jean‐Marc Dumonceau, Myriam Delhaye, Isabelle Annessi‐Ramseyer, Jean‐Louis Frossard, Yohann Couté, Annarita Farina

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First‐in‐human, randomized, double‐blind, placebo‐controlled, dose escalation trial of the anti‐herpes simplex virus monoclonal antibody HDIT101 in healthy volunteers by Antje Blank, Nicolas Hohmann, Marlen Dettmer, Anette Manka‐Stuhlik, Gerd Mikus, Felicitas Stoll, Marlies Stützle‐Schnetz, Daniel Thomas, Evelyn Exner, Beate Schmitt‐Bormann, Torsten Schaller, Rico Laage, Oliver Schönborn‐Kellenberger, Michaela Arndt, Walter E. Haefeli, Jürgen Krauss

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Assessment of the Building Collaborative Research Capacity Model: Bridging the community-academic researcher divide by Tabia Akintobi, Donoria Wilkerson, Kirsten Rodgers, Cam Escoffery, Regine Haardörfer, Michelle Kegler

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Assessing the net financial benefits of employing digital endpoints in clinical trials by Joseph A. DiMasi, Abigail Dirks, Zachary Smith, Sarah Valentine, Jennifer C. Goldsack, Thomas Metcalfe, Upinder Grewal, Lada Leyens, Ute Conradi, Daniel Karlin, Lesley Maloney, Kenneth A. Getz, Bert Hartog

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Risk Assessment of Drug‐Induced Long QT Syndrome for Some COVID‐19 Repurposed Drugs by Veronique Michaud, Pamela Dow, Sweilem B. Al Rihani, Malavika Deodhar, Meghan Arwood, Brian Cicali, Jacques Turgeon

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Pharmacogenetic variants and risk of remdesivir‐associated liver enzyme elevations in Million Veteran Program participants hospitalized with COVID‐19 by Sony Tuteja, Zhihong Yu, Otis Wilson, Hua‐Chang Chen, Frank Wendt, Cecilia P. Chung, Shailja C. Shah, Christine M. Hunt, Ayako Suzuki, Catherine Chanfreau, Bryan R. Gorman, Jacob Joseph, Shiuh‐Wen Luoh, Valerio Napolioni, Cassianne Robinson‐Cohen, Ran Tao, Jin Zhou, Kyong‐Mi Chang, Adriana M. Hung, the VA Million Veteran Program COVID‐19 Science Initiative

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An innovative phase I study in healthy subjects to determine the mass balance, elimination, metabolism, and absolute bioavailability of mitapivat by Chandra Prakash, Heidi Mangus, Yan Yan, Hua Yang, Varsha Iyer

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Effect of Crohn's Disease on Villous Length and CYP3A4 Expression in the Pediatric Small Intestine by Carrie A Vyhlidal, Brian D. Chapron, Atif Ahmed, Vivekanand Singh, Rebecca Casini, Valentina Shakhnovich

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