Publications by authors named "Yuching Yang"

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Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.
Abdullah Al Shoyaib, Arian Emami Riedmaier, Anita Kumar, Partha Roy, Neil John Parrott, Lanyan Fang, Nilufer Tampal, Yuching Yang, Rebeka Jereb, Liang Zhao

CPT Pharmacometrics Syst Pharmacol· May 2023

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FDA Approval Summary: Datopotamab Deruxtecan-dlnk for Treatment of Patients with Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer.
Melanie Royce, Mirat Shah, Lijun Zhang, Joyce Cheng, Mary Kate Bonner, Yuching Yang

Clin Cancer Res· November 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, Yuching Yang

Clin Cancer Res· November 2025

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US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting.
Jennifer J Gao, Tatiana M Prowell, Haley Gittleman, Joyce Cheng, Mallorie Fiero, Yuching Yang

J Clin Oncol· October 2025

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Considerations for Regulatory Reusability of Dynamic Tools in the New Drug Development.
Jiang Liu, Yuching Yang, Joga Gobburu, Cynthia J Musante, Martin Klein

Pharm Res· May 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, Yuching Yang

Clin Cancer Res· April 2025

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Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report.
Jane P F Bai, Guansheng Liu, Miao Zhao, Jie Wang, Ye Xiong, Yuching Yang

CPT Pharmacometrics Syst Pharmacol· December 2024

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Developing Components of an Integrated mHealth Dietary Intervention for Mexican Immigrant Farmworkers: Feasibility Usability Study of a Food Photography Protocol for Dietary Assessment.
Isabel Diana Fernandez, Yu-Ching Yang, Wonkyung Chang, Amber Kautz, Karen Farchaus Stein

JMIR Form Res· December 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, Yuching Yang, Yang Nan

Clin Cancer Res· August 2024

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FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma.
Deepti Telaraja, Yvette L Kasamon, Justin S Collazo, Ruby Leong, Kun Wang, Yuching Yang

Clin Cancer Res· January 2024

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Genomic analysis of penicillin-binding proteins and recombination events in an emerging amoxicillin- and meropenem-resistant PMEN3 (Spain-3, ST156) variant in Taiwan and comparison with global descendants of this lineage.
Yi-Yin Chen, Hsin Chi, Wei-Chao Liao, Shiao-Wen Li, Yu-Ching Yang

Microbiol Spectr· December 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

J Clin Pharmacol· November 2023

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FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement.
Timil H Patel, Leigh Marcus, M Naomi Horiba, Martha Donoghue, Somak Chatterjee, Yangbing Li, Yuching Yang

Clin Cancer Res· March 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, Yuching Yang

Clin Cancer Res· February 2023

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FDA approval summary for lonafarnib (Zokinvy) for the treatment of Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies.
Mari Suzuki, Linda J B Jeng, Solomon Chefo, Yan Wang, Dionne Price, Yuching Yang

Genet Med· February 2023

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Human radiolabeled mass balance studies supporting the FDA approval of new drugs.
Anuradha Ramamoorthy, Girish Bende, Edwin Chiu Yuen Chow, Hristina Dimova, Neil Hartman, Yuching Yang

Clin Transl Sci· November 2022

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FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy.
Donna Przepiorka, Robert Q Le, Alexei Ionan, Ruo-Jing Li, Ying-Hong Wang, Yuching Yang

Clin Cancer Res· June 2022

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Integration of Engineered Delivery with the Pharmacokinetics of Medical Candidates via Physiology-Based Pharmacokinetics.
Yuching Yang, Xinyuan Zhang

Methods Mol Biol· April 2022

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Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction.
Jianghong Fan, Yuching Yang, Manuela Grimstein, Xinyuan Zhang, Eliford Kitabi

Clin Pharmacol Ther· March 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, Yuching Yang

Clin Pharmacol Ther· March 2022

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Romosozumab Enhances Vertebral Bone Structure in Women With Low Bone Density.
Kenneth Es Poole, Graham M Treece, Rose A Pearson, Andrew H Gee, Michael A Bolognese, Yu-Ching Yang

J Bone Miner Res· February 2022

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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary.
Daphney Jean, Kunal Naik, Lauren Milligan, Stephen Hall, Shiew Mei Huang, Yuching Yang

CPT Pharmacometrics Syst Pharmacol· November 2021

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Anti-SARS-CoV-2 Repurposing Drug Database: Clinical Pharmacology Considerations.
Xinyuan Zhang, Yuching Yang, Manuela Grimstein, Guansheng Liu, Eliford Kitabi

CPT Pharmacometrics Syst Pharmacol· September 2021

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Bacterial factors required for Streptococcus pneumoniae coinfection with influenza A virus.
Yi-Yin Chen, Ching-Tai Huang, Shiao-Wen Li, Yi-Jiun Pan, Tzu-Lung Lin, Yu-Ching Yang

J Biomed Sci· August 2021

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

J Clin Pharmacol· June 2021

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