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SaveUsing Machine Learning to Determine a Suitable Patient Population for Anakinra for the Treatment of COVID-19 Under the Emergency Use Authorization
Liu, Qi; Nair, Raj; Huang, Ruihao; Zhu, Hao; Anderson, Austin; Belen, Ozlem; Tran, Van; Chiu, Rebecca; Higgins, Karen; Chen, Jianmeng; He, Lei; Doddapaneni, Suresh; Huang, Shiew-Mei; Nikolov, Nikolay P.; Zineh, Issam Share Save Clinical Pharmacology Approaches to Support Approval of New Routes of Administration for Therapeutic ProteinsWang, Yow-Ming C.; Ji, Ping; Hariharan, Sudarshan; Wang, Jie; Okusanya, Olanrewaju; Abuasal, Bilal; Zhu, Hao; Madabushi, Rajanikanth; Huang, Shiew Mei; Zineh, Issam Share Save Share Save Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and ProteinsFletcher, Elimika Pfuma; Sahre, Martina; Hon, Yuen Yi; Balakrishnan, Anand; Zhou, Lin; Sun, Qin; Wang, Jie; Maxfield, Kimberly; Naik, Raajan; Huang, Shiew Mei; Wang, Yow-Ming C. Share Save The Association Between Baseline Hepatic or Renal Function and Clinical Outcomes for Patients With Non-Small Cell Lung Cancer Treated With a PD-1/PD-L1 Blocking Antibody Using Real-World and Trial DataLiu, Qi; Mathur, Raina; Xu, Yuan; Torres, Aracelis Z.; Miksad, Rebecca A.; Liu, Chao; Smithson, Haixia; Wang, Yaning; Zhu, Hao; Booth, Brian; Huang, Shiew-Mei; Zhi, Jizu; Sridhara, Rajeshwari; Blumenthal, Gideon Michael; Larkins, Erin; Mishra-Kalyani, Pallavi S.; Rivera, Donna R.; Kluetz, Paul G.; Sharon, Elad Share Save Share Save Share Save Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021Liu, Qi; Huang, Ruihao; Hsieh, Julie; Zhu, Hao; Tiwari, Mo; Liu, Guansheng; Jean, Daphney; ElZarrad, M. Khair; Fakhouri, Tala; Berman, Steven; Dunn, Billy; Diamond, Matthew C.; Huang, Shiew-Mei Share Save Share Save Share Save Roadmap to 2030 for Drug Evaluation in Older AdultsLiu, Qi; Schwartz, Janice B.; Slattum, Patricia W.; Lau, S. W. Johnny; Guinn, Daphne; Madabushi, Rajanikanth; Burckart, Gilbert; Califf, Robert; Cerreta, Francesca; Cho, Carolyn; Cook, Jack; Gamerman, Jamie; Goldsmith, Paul; van der Graaf, Piet H.; Gurwitz, Jerry H.; Haertter, Sebastian; Hilmer, Sarah; Huang, Shiew-Mei; Inouye, Sharon K.; Kanapuru, Bindu; Pirmohamed, Munir; Posner, Phil; Radziszewska, Barbara; Keipp Talbot, H.; Temple, Robert Share Save 3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory considerationWang, Hongbing; Brown, Paul C.; Chow, Edwin C. Y.; Ewart, Lorna; Ferguson, Stephen S.; Fitzpatrick, Suzanne; Freedman, Benjamin S.; Guo, Grace L.; Hedrich, William; Heyward, Scott; Hickman, James; Isoherranen, Nina; Li, Albert P.; Liu, Qi; Mumenthaler, Shannon M.; Polli, James; Proctor, William R.; Ribeiro, Alexandre; Wang, Jian-Ying; Wange, Ronald L.; Huang, Shiew-Mei Share Save Share Save Share Save Evaluating Patients With Impaired Renal Function During Drug Development: Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee MeetingSahre, Martina D.; Milligan, Lauren; Madabushi, Rajanikanth; Graham, Richard A.; Reynolds, Kellie S.; Terzic, Andre; Benjamin, Jessica; Burckart, Gilbert J.; Huang, Shiew-Mei; Schuck, Robert; Thompson, Aliza M.; Zineh, Issam Share Save Share Save Share Save Share Save Connecting Hydroxychloroquine In Vitro Antiviral Activity to In Vivo Concentration for Prediction of Antiviral Effect: A Critical Step in Treating Patients With Coronavirus Disease 2019Fan, Jianghong; Zhang, Xinyuan; Liu, Jiang; Yang, Yuching; Zheng, Nan; Liu, Qi; Bergman, Kimberly; Reynolds, Kellie; Huang, Shiew-Mei; Zhu, Hao; Wang, Yaning Share Save 
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