Publications by authors named "Stacy Shord"

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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
Stacy S Shord, Cong Chen, Jin Y Jin, Scott Van Wart, Sarah K Martin

Clin Cancer Res· December 2025

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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early-Phase Trials Using Innovative Trial Designs and Biomarkers.
Olanrewaju O Okusanya, Gabriela I Patilea-Vrana, Anthony Sireci, Alexia Iasonos, Brad A Davidson, Stacy S Shord

Clin Cancer Res· December 2025

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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-in-Human Trials.
Hao Zhu, Alex N Phipps, Ying Yuan, Brad A Davidson, Stacy S Shord

Clin Cancer Res· December 2025

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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, Stacy S Shord

Clin Cancer Res· November 2025

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Using Quantitative Approaches to Optimize Dosages for New Combinations and Subsequent Indications for Oncology Drugs.
Wei Gao, Jiang Liu, Cynthia J Musante, Hao Zhu, Matthew Thompson, Stacy S Shord

Clin Pharmacol Ther· October 2025

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Dosage Optimization of Pediatric Oncology Products: Our Patients Deserve Better.
Kristin M Wessel, Nicole Drezner, Stacy S Shord, Mirat Shah, Marc R Theoret

Clin Cancer Res· July 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, Stacy S Shord

Clin Cancer Res· April 2025

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Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding.
Jorge E Cortes, Elisabetta Abruzzese, Elyce H Cardonick, Sonia Hernández-Díaz, Jamie Gutierrez, Stacy S Shord

Clin Cancer Res· September 2024

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Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs.
Atiqur Rahman, Mirat Shah, Stacy S Shord

Clin Pharmacol Ther· September 2024

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Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress.
Rosane Charlab, Ruby Leong, Stacy S Shord, Gregory H Reaman

Cold Spring Harb Perspect Med· April 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, Stacy S Shord

Clin Cancer Res· January 2024

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Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics.
Xinxin Yang, Manuela Grimstein, Michelle Pressly, Elimika Pfuma Fletcher, Stacy Shord

Pharmaceutics· December 2023

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US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer.
Stacy S Shord, Hao Zhu, Jiang Liu, Atiqur Rahman, Brian Booth

CPT Pharmacometrics Syst Pharmacol· November 2023

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Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy.
Ruby Leong, Manuela Grimstein, Peter DeMaria, Kelly J Norsworthy, Elimika Pfuma Fletcher, Stacy Shord

J Clin Pharmacol· June 2023

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Study design considerations to assess the impact of potential drug-drug interactions in first-in-human studies in oncology drug development.
Sriram Subramaniam, Stacy S Shord, Ruby Leong, Kelly Norsworthy, Atiqur Rahman

Clin Transl Sci· May 2023

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FDA Approval Summary: Selumetinib for Plexiform Neurofibroma.
Denise Casey, Suzanne Demko, Arup Sinha, Pallavi S Mishra-Kalyani, Yuan-Li Shen, Stacy S Shord

Clin Cancer Res· August 2021

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FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs.
Paul G Kluetz, Patricia Keegan, George D Demetri, Katherine Thornton, Joohee Sul, Stacy S Shord

Clin Cancer Res· February 2021

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FDA Approval Summary: (Daunorubicin and Cytarabine) Liposome for Injection for the Treatment of Adults with High-Risk Acute Myeloid Leukemia.
Aviva C Krauss, Xin Gao, Liang Li, Michael L Manning, Paresma Patel, Stacy S Shord

Clin Cancer Res· May 2019

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FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis.
Yvette L Kasamon, Chia-Wen Ko, Sriram Subramaniam, Lian Ma, Yuching Yang, Stacy Shord

Oncologist· December 2018

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FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim-Chester Disease with the V600 Mutation.
Patricia A Oneal, Virginia Kwitkowski, Lola Luo, Yuan Li Shen, Sriram Subramaniam, Stacy Shord

Oncologist· December 2018

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FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome.
Robert Q Le, Liang Li, Weishi Yuan, Stacy S Shord, Lei Nie

Oncologist· August 2018

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FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy.
Vishal Bhatnagar, Nicole J Gormley, Lola Luo, Yuan Li Shen, Rajeshwari Sridhara, Stacy Shord

Oncologist· November 2017

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The Role of Clinical Pharmacology in Oncology Dose Selection: Advances and Opportunities in Personalized Medicine.
Stacy S Shord

J Clin Pharmacol· October 2017

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FDA Approval Summary: Sonidegib-Response.
Stacy S Shord, Denise Casey, Hong Zhao, Suzanne Demko, Patricia Keegan

Clin Cancer Res· October 2017

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FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma.
Denise Casey, Suzanne Demko, Stacy Shord, Hong Zhao, Huanyu Chen

Clin Cancer Res· May 2017

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