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The AAPS Journal
|
January 10, 2024
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, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
September 26, 2025
Evaluation and Mitigation of Time-Dependent Confounding Effects in Conventional Exposure-Response Analyses for Oncology Drugs
Xuefen Yin, Ye Xiong, Youwei Bi, et al.
Clinical Pharmacology and Therapeutics
|
October 16, 2024
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, et al.
The Oncologist
|
May 8, 2026
Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products
Ye Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.
The Oncologist
|
May 4, 2026
Shifting a Paradigm: Highlights of Model Informed Drug Development in Dosage Selection and Optimization for Oncology Products
Ye Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.
Clinical Pharmacology and Therapeutics
|
November 22, 2021
Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic
Ye Xiong, Jianghong Fan, Eliford Kitabi, et al.
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|
May 4, 2023
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, et al.
The Oncologist
|
February 2, 2018
Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib
Lorraine Pelosof, Steven Lemery, Sandra Casak, et al.
Journal of Clinical Pharmacology
|
September 11, 2019
Role of Model-Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling
Youwei Bi, Jiang Liu, Lingjue Li, et al.
Journal of Clinical Pharmacology
|
June 29, 2021
Model-Informed Drug Development in Pediatric Dose Selection
Youwei Bi, Jiang Liu, Fang Li, et al.
Page
of 4
Search research articles
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Showing results (11-20 of 38) with videos related to
Sort By:
Page
of 4
The AAPS Journal
|
January 10, 2024
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, et al.
CPT: Pharmacometrics & Systems Pharmacology
|
September 26, 2025
Evaluation and Mitigation of Time-Dependent Confounding Effects in Conventional Exposure-Response Analyses for Oncology Drugs
Xuefen Yin, Ye Xiong, Youwei Bi, et al.
Clinical Pharmacology and Therapeutics
|
October 16, 2024
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, et al.
The Oncologist
|
May 8, 2026
Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products
Ye Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.
The Oncologist
|
May 4, 2026
Shifting a Paradigm: Highlights of Model Informed Drug Development in Dosage Selection and Optimization for Oncology Products
Ye Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.
Clinical Pharmacology and Therapeutics
|
November 22, 2021
Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic
Ye Xiong, Jianghong Fan, Eliford Kitabi, et al.
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
|
May 4, 2023
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, et al.
The Oncologist
|
February 2, 2018
Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib
Lorraine Pelosof, Steven Lemery, Sandra Casak, et al.
Journal of Clinical Pharmacology
|
September 11, 2019
Role of Model-Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling
Youwei Bi, Jiang Liu, Lingjue Li, et al.
Journal of Clinical Pharmacology
|
June 29, 2021
Model-Informed Drug Development in Pediatric Dose Selection
Youwei Bi, Jiang Liu, Fang Li, et al.
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of 4