Publications by authors named "Youwei Bi"

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Evaluation and Mitigation of Time-Dependent Confounding Effects in Conventional Exposure-Response Analyses for Oncology Drugs.
Xuefen Yin, Ye Xiong, Youwei Bi, Xin Wei, Hong Zhao

CPT Pharmacometrics Syst Pharmacol· December 2025

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FDA Approval Summary: Vorasidenib for IDH-Mutant Grade 2 Astrocytoma or Oligodendroglioma Following Surgery.
Michael I Barbato, Amy K Barone, Stephanie L Aungst, Claudia P Miller, Suryatheja Ananthula, Youwei Bi

Clin Cancer Res· November 2025

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Approval of Upadacitinib in Pediatric Patients with Active Polyarticular Juvenile Idiopathic Arthritis or Active Psoriatic Arthritis: A Regulatory Perspective.
Lei He, Da Zhang, Eric J Gapud, Suzette Peng, Ozlem Belen, Youwei Bi

J Clin Pharmacol· September 2025

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FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma.
Sonia Singh, Diana Bradford, Somak Chatterjee, Xiaoxue Li, Stephanie L Aungst, Youwei Bi

Clin Cancer Res· April 2025

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Model-Informed Drug Development-Based Approval of Intravenous Secukinumab for the Treatment of Adult Patients with Active Psoriatic Arthritis, Active Ankylosing Spondylitis, and Active Non-Radiographic Axial Spondyloarthritis.
Dipak S Pisal, Yangbing Li, Amit Golding, Raj Nair, Nikolay P Nikolov, Youwei Bi

Clin Pharmacol Ther· February 2025

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Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in Pediatric Recipients of Heart or Liver Transplants: A Regulatory Perspective.
Amer Al-Khouja, Nadia Chaudhri, Ergun Velidedeoglu, Ozlem Belen, Youwei Bi

Clin Pharmacol Ther· September 2024

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FDA Approval Summary: Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer.
Michael J Fusco, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Brian J Christmas, Youwei Bi

Clin Cancer Res· August 2024

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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.
Michael I Barbato, Diana Bradford, Yi Ren, Stephanie L Aungst, Claudia P Miller, Yangbing Li, Youwei Bi

Clin Cancer Res· August 2024

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FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma.
Michael I Barbato, Jeannette Nashed, Diana Bradford, Yi Ren, Sachia Khasar, Yangbing Li, Youwei Bi

Clin Cancer Res· January 2024

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Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products-a Meeting Report.
Eleftheria Tsakalozou, Lanyan Fang, Youwei Bi, Michiel van den Heuvel, Tausif Ahmed

AAPS J· January 2024

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How to select the initial dose for a pediatric study?
Jingjing Ye, Youwei Bi, Naitee Ting

J Biopharm Stat· November 2023

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FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer.
Sandra J Casak, M Naomi Horiba, Mengdie Yuan, Joyce Cheng, Steven J Lemery, Yangbing Li, Youwei Bi

Clin Cancer Res· November 2023

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Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective.
Xiaolei Pan, Li Wang, Jiang Liu, Justin C Earp, Yuching Yang, Youwei Bi

J Clin Pharmacol· November 2023

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FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements.
Shruti U Gandhy, Sandra J Casak, Sirisha L Mushti, Joyce Cheng, Sriram Subramaniam, Youwei Bi

Clin Cancer Res· October 2023

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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Elizabeth S Duke, Diana Bradford, Michelle Marcovitz, Anup K Amatya, Pallavi S Mishra-Kalyani, Yangbing Li, Youwei Bi

Clin Cancer Res· September 2023

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US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer.
Oladimeji Akinboro, Nicole Drezner, Anup Amatya, Jin Runyan, Jeanne Fourie-Zirkelbach, Youwei Bi

J Clin Oncol· June 2023

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FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Elizabeth S Duke, Liza Stapleford, Nicole Drezner, Anup K Amatya, Pallavi S Mishra-Kalyani, Youwei Bi, Rama Kamesh Bikkavilli

Clin Cancer Res· February 2023

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Model-Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases.
Ruo-Jing Li, Lian Ma, Fang Li, Liang Li, Youwei Bi, Yangbing Li

J Clin Pharmacol· December 2022

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FDA Approval Summary: Cabozantinib for Differentiated Thyroid Cancer.
Elizabeth S Duke, Amy K Barone, Somak Chatterjee, Pallavi S Mishra-Kalyani, Yuan-Li Shen, Youwei Bi

Clin Cancer Res· October 2022

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FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC.
Oladimeji Akinboro, Erin Larkins, Lee H Pai-Scherf, Luckson N Mathieu, Yi Ren, Youwei Bi

Clin Cancer Res· June 2022

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FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.
Erica C Nakajima, Nicole Drezner, Xiaoxue Li, Pallavi S Mishra-Kalyani, Yajun Liu, Youwei Bi

Clin Cancer Res· April 2022

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Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic.
Ye Xiong, Jianghong Fan, Eliford Kitabi, Xinyuan Zhang, Youwei Bi

Clin Pharmacol Ther· March 2022

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FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma.
Erica C Nakajima, Paz J Vellanki, Erin Larkins, Somak Chatterjee, Pallavi S Mishra-Kalyani, Youwei Bi, Missiratch Biable

Clin Cancer Res· February 2022

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FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations.
Luckson N Mathieu, Erin Larkins, Oladimeji Akinboro, Pourab Roy, Anup K Amatya, Youwei Bi, Yangbing Li

Clin Cancer Res· January 2022

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Model-Informed Drug Development in Pediatric Dose Selection.
Youwei Bi, Jiang Liu, Fang Li, Jingyu Yu, Atul Bhattaram

J Clin Pharmacol· June 2021

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