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Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced MelanomaWeber, Jeffrey S ; Hodi, F Stephen ; Wolchok, Jedd D ; Topalian, Suzanne L ; Schadendorf, Dirk ; Larkin, James ; Sznol, Mario ; Long, Georgina V ; Li, Hewei ; Waxman, Ian M ; Jiang, Joel ; Robert, CarolineJournal of clinical oncology, 2017-03, Vol.35 (7), p.785-792 [Periódico revisado por pares]United StatesTexto completo disponível |
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The COVID-19 vaccine development landscapeThanh Le, Tung ; Andreadakis, Zacharias ; Kumar, Arun ; Gómez Román, Raúl ; Tollefsen, Stig ; Saville, Melanie ; Mayhew, StephenNature reviews. Drug discovery, 2020-05, Vol.19 (5), p.305-306 [Periódico revisado por pares]England: Nature Publishing GroupTexto completo disponível |
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Material Type: Artigo
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Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trialsAtkins, Johnique T ; George, Goldy C ; Hess, Kenneth ; Marcelo-Lewis, Kathrina L ; Yuan, Ying ; Borthakur, Gautam ; Khozin, Sean ; LoRusso, Patricia ; Hong, David SBritish journal of cancer, 2020-11, Vol.123 (10), p.1496-1501 [Periódico revisado por pares]England: Nature Publishing GroupTexto completo disponível |
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Material Type: Artigo
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Embracing model-based designs for dose-finding trialsLove, Sharon B ; Brown, Sarah ; Weir, Christopher J ; Harbron, Chris ; Yap, Christina ; Gaschler-Markefski, Birgit ; Matcham, James ; Caffrey, Louise ; McKevitt, Christopher ; Clive, Sally ; Craddock, Charlie ; Spicer, James ; Cornelius, VictoriaBritish journal of cancer, 2017-07, Vol.117 (3), p.332-339 [Periódico revisado por pares]England: Nature Publishing GroupTexto completo disponível |
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Material Type: Artigo
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An oral SARS-CoV-2 M pro inhibitor clinical candidate for the treatment of COVID-19Owen, Dafydd R ; Allerton, Charlotte M N ; Anderson, Annaliesa S ; Aschenbrenner, Lisa ; Avery, Melissa ; Berritt, Simon ; Boras, Britton ; Cardin, Rhonda D ; Carlo, Anthony ; Coffman, Karen J ; Dantonio, Alyssa ; Di, Li ; Eng, Heather ; Ferre, RoseAnn ; Gajiwala, Ketan S ; Gibson, Scott A ; Greasley, Samantha E ; Hurst, Brett L ; Kadar, Eugene P ; Kalgutkar, Amit S ; Lee, Jack C ; Lee, Jisun ; Liu, Wei ; Mason, Stephen W ; Noell, Stephen ; Novak, Jonathan J ; Obach, R Scott ; Ogilvie, Kevin ; Patel, Nandini C ; Pettersson, Martin ; Rai, Devendra K ; Reese, Matthew R ; Sammons, Matthew F ; Sathish, Jean G ; Singh, Ravi Shankar P ; Steppan, Claire M ; Stewart, Al E ; Tuttle, Jamison B ; Updyke, Lawrence ; Verhoest, Patrick R ; Wei, Liuqing ; Yang, Qingyi ; Zhu, YuaoScience (American Association for the Advancement of Science), 2021-12, Vol.374 (6575), p.1586-1593 [Periódico revisado por pares]United StatesTexto completo disponível |
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Material Type: Artigo
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FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLCNakajima, Erica C ; Drezner, Nicole ; Li, Xiaoxue ; Mishra-Kalyani, Pallavi S ; Liu, Yajun ; Zhao, Hong ; Bi, Youwei ; Liu, Jiang ; Rahman, Atiqur ; Wearne, Emily ; Ojofeitimi, Idara ; Hotaki, Lauren Tesh ; Spillman, Dianne ; Pazdur, Richard ; Beaver, Julia A ; Singh, HarpreetClinical cancer research, 2022-04, Vol.28 (8), p.1482-1486 [Periódico revisado por pares]United StatesTexto completo disponível |
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Material Type: Artigo
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Commentary on the EMA Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal productsGerven, Joop ; Bonelli, MiltonBritish journal of clinical pharmacology, 2018-07, Vol.84 (7), p.1401-1409 [Periódico revisado por pares]England: John Wiley and Sons IncTexto completo disponível |
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Material Type: Artigo
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Phase I–II clinical trial design: a state-of-the-art paradigm for dose findingYan, F. ; Thall, P.F. ; Lu, K.H. ; Gilbert, M.R. ; Yuan, Y.Annals of oncology, 2018-03, Vol.29 (3), p.694-699 [Periódico revisado por pares]England: Elsevier LtdTexto completo disponível |
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Material Type: Artigo
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A utility‐based Bayesian optimal interval (U‐BOIN) phase I/II design to identify the optimal biological dose for targeted and immune therapiesZhou, Yanhong ; Lee, J. Jack ; Yuan, YingStatistics in medicine, 2019-12, Vol.38 (28), p.5299-5316 [Periódico revisado por pares]England: Wiley Subscription Services, IncTexto completo disponível |
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Material Type: Artigo
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Therapeutic Antisense Oligonucleotides Are Coming of AgeBennett, C. FrankAnnual review of medicine, 2019-01, Vol.70 (1), p.307-321 [Periódico revisado por pares]United States: Annual ReviewsTexto completo disponível |