Resultados de búsqueda - "Center for Drug Evaluation and Research"

Spina Bifida and Carbamazepine por J Gordon Millichap

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Mortality in Antiepileptic Drug Trials por J Gordon Millichap

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Opportunities and challenges for applying model‐informed drug development approaches to gene therapies por Artur Belov, Kimberly Schultz, Richard Forshee, Million A. Tegenge

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Findings on In Vitro Transporter-Mediated Drug Interactions and Their Follow-Up Actions for Labeling: Analysis of Drugs Approved by US FDA between 2017 and 2021 por Kyeong-Ryoon Lee, Ji-Eun Chang, Jongmin Yoon, Hyojeong Jin, Yoon-Jee Chae

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A network of regulatory innovations to improve FDA quality assessments of human drug applications por Russie Tran, Grace Fraser, Adam C. Fisher, Sau L. Lee, Ashley Boam, Stelios Tsinontides, Jennifer Maguire, Lawrence X. Yu, Susan Rosencrance, Steven Kozlowski, Don Henry

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Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers por Nicolas Abrigo, Connie Ruzicka, Patrick Faustino, Neil Stiber, Agnes NguyenPho, Thomas O'Connor, Diaa Shakleya

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Sterilization plan of the used metered dose inhalers (MDI) to avoid wastage amid COVID-19 pandemic drug shortage por Ali Elbeddini

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The TwistDock workflow for evaluation of bivalent Smac mimetics targeting XIAP por Huang Q, Peng Y, Peng Y, Wei D, Wei Y, Feng S

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Unsubstantiated health claims for COVID-19 infections are led by cannabidiol: return of snake oil medicine por Allan Tran, Natasha Y. Sheikhan, Tania Sheikhan, Dominik A. Nowak, Theodore J. Witek

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Assessing the immunogenicity risk of salmon calcitonin peptide impurities using in silico and in vitro methods por Brian J. Roberts, Aimee E. Mattei, Kristina E. Howard, James L. Weaver, Hao Liu, Sandra Lelias, William D. Martin, Daniela Verthelyi, Eric Pang, Katie J. Edwards, Anne S. De Groot

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