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Pharmaceutical Research|September 26, 2012
Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidateJeanne Fourie Zirkelbach, Andre J Jackson, Yaning Wang, et al.Journal of Pharmaceutical Sciences|August 29, 2012
Bioequivalence of long half-life drugs--informative sampling determination--using truncated area in parallel-designed studies for slow sustained-release formulationsAhmed El-Tahtawy, Ferrin Harrison, Jeanne Fourie Zirkelbach, et al.Journal of Patient-Reported Outcomes|November 17, 2023
Use of patient-reported outcomes (PRO) data to complement exposure-response analysis in early clinical cancer drug developmentHuiming Xia, Brian P Booth, Yaning Wang, et al.The Oncologist|May 4, 2026
Shifting a Paradigm: Highlights of Model Informed Drug Development in Dosage Selection and Optimization for Oncology ProductsYe Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, et al.The Oncologist|May 8, 2026
Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology productsYe Xiong, Robyn Konicki, Jeanne Fourie Zirkelbach, 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 CancerOladimeji 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 SorafenibLorraine Pelosof, Steven Lemery, Sandra Casak, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|February 10, 2017
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic MelanomaAmy Barone, Maitreyee Hazarika, Marc R Theoret, et al.Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology|September 12, 2022
Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to PatientsJeanne Fourie Zirkelbach, Mirat Shah, Jonathon Vallejo, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|October 24, 2013
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summaryPaul G Kluetz, Yang-Min Ning, V Ellen Maher, et al.Pageof 3