Zobrazeno 1 - 10 of 136 pro vyhledávání: '"Fourie Zirkelbach J"'
1
Akademický článek
FDA Approval Summary: Capecitabine Labeling Update under Project Renewal.
Autor: Agrawal S; United States Food and Drug Administration, Silver Spring, MD, United States., Lee C; United States Food and Drug Administration, Silver Spring, Maryland, United States., Pierce WF; Food and Drug Administration, Silver Spring, Maryland, United States., Everhart E; United States Food and Drug Administration, Silver Spring, MD, United States., King-Ducre A; Food and Drug Administration, Silver Spring, Maryland, United States., Royce M; United States Food and Drug Administration, Silver Spring, Maryland, United States., Osgood CL; United States Food and Drug Administration, Silver Spring, MD, United States., Amiri-Kordestani L; Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, United States., Chiu HJ; Food and Drug Administration, Silver Spring, Maryland, United States., Ricks TK; United States Food and Drug Administration, Silver Spring, MD, United States., Pan L; United States Food and Drug Administration, Silver Spring, Maryland, United States., Fourie Zirkelbach J; United States Food and Drug Administration, Silver Spring, Maryland, United States., Charlab R; United States Food and Drug Administration, Silver Spring, MD, United States., Pacanowski M; United States Food and Drug Administration, Silver Spring, MD, United States., Kim T; United States Food and Drug Administration, Silver Spring, MD, United States., Pazdur R; United States Food and Drug Administration, Silver Spring, MD, United States., Kluetz PG; Food and Drug Administration, Silver Spring, MD, United States., Gao JJ; United States Food and Drug Administration, Silver Spring, MD, United States.
Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Oct 08. Date of Electronic Publication: 2024 Oct 08.
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2
Akademický článek
Use of patient-reported outcomes (PRO) data to complement exposure-response analysis in early clinical cancer drug development.
Autor: Xia H; Bristol Myers Squibb, Princeton, USA., Booth BP; Division of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US Food and Drug Administration, Silver Spring, USA., Wang Y; Greaterna Science and Technology, Shanghai, China., Fan C; AstraZeneca, Gaithersburg, USA., Bhatnagar V; Oncology Center of Excellence, Office of New Drugs, CDER, US Food and Drug Administration, Silver Spring, USA., Kluetz P; Oncology Center of Excellence, Office of New Drugs, CDER, US Food and Drug Administration, Silver Spring, USA., Fourie Zirkelbach J; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US Food and Drug Administration, FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD, 20903, USA. Jeanne.fouriezirkelbach@fda.hhs.gov.
Publikováno v: Journal of patient-reported outcomes [J Patient Rep Outcomes] 2023 Nov 17; Vol. 7 (1), pp. 116. Date of Electronic Publication: 2023 Nov 17.
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3
Akademický článek
FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors.
Autor: Duke ES; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Bradford D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Marcovitz M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Amatya AK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mishra-Kalyani PS; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Nguyen E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Price LSL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fourie Zirkelbach J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Bi Y; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kraft J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Dorff SE; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Scepura B; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Stephenson M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ojofeitimi I; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Nair A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Han Y; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Tezak Z; Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland., Lemery SJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Larkins E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 Sep 15; Vol. 29 (18), pp. 3573-3578.
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4
Akademický článek
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.
Autor: Akinboro O; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Drezner N; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Amatya A; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Runyan J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Fourie-Zirkelbach J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Zhao M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Bi Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Korsah K; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Mixter B; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD., Tang S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Larkins E; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD., Pazdur R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD., Beaver JA; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD., Singh H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD.
Publikováno v: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Jun 10; Vol. 41 (17), pp. 3249-3259. Date of Electronic Publication: 2023 May 04.
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5
Akademický článek
FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement.
Autor: Patel TH; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Marcus L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Horiba MN; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Donoghue M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chatterjee S; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Mishra-Kalyani PS; Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Schuck RN; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang X; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fourie Zirkelbach J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Charlab R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Liu J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yang Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lemery SJ; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Fashoyin-Aje LA; Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2023 Mar 01; Vol. 29 (5), pp. 838-842.
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6
Akademický článek
Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients.
Autor: Fourie Zirkelbach J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Shah M; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Vallejo J; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Cheng J; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Ayyoub A; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Liu J; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Hudson R; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Sridhara R; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Ison G; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Amiri-Kordestani L; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Tang S; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Gwise T; Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Rahman A; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD., Pazdur R; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD., Theoret MR; Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD.
Publikováno v: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2022 Oct 20; Vol. 40 (30), pp. 3489-3500. Date of Electronic Publication: 2022 Sep 12.
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7
Akademický článek
FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1-High NSCLC.
Autor: Akinboro O; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Larkins E; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Pai-Scherf LH; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Mathieu LN; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Ren Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Cheng J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Fu W; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Bi Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Kalavar S; Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Jafri S; Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Mishra-Kalyani PS; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Fourie Zirkelbach J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Li H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Zhao H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., He K; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Helms WS; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Chuk MK; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Wang M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Bulatao I; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Herz J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Osborn BL; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Xu Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Liu J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Gong Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Sickafuse S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Cohen R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Donoghue M; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland., Singh H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland.
Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Jun 01; Vol. 28 (11), pp. 2221-2228.
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8
Akademický článek
FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma.
Autor: Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. elaine.chang@fda.hhs.gov., Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhao M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zahalka E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ricks TK; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fourie Zirkelbach J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Qiu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chen XH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Bhatnagar V; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Goldberg KB; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Ibrahim A; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Beaver JA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Publikováno v: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Feb 01; Vol. 28 (3), pp. 441-445. Date of Electronic Publication: 2021 Aug 20.
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9
Akademický článek
Determining doses for backfill cohorts based on patient-reported outcome.
Autor: Chen, Xin1 (AUTHOR), Zhang, Jingyi1 (AUTHOR), Li, Bosheng1 (AUTHOR), Yan, Fangrong1 (AUTHOR) f.r.yan@163.com
Publikováno v: BMC Medical Research Methodology. 11/8/2024, Vol. 24 Issue 1, p1-12. 12p.
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10
Akademický článek
Histology Agnostic Drug Development: An Updated Review.
Autor: Nguyen, Kevin1 (AUTHOR) knguyen49@student.touro.edu, Fama, Karina1 (AUTHOR), Mercado, Guadalupe1 (AUTHOR), Myat, Yin2,3 (AUTHOR), Thein, Kyaw1,4,5 (AUTHOR) kyaw.thein@usoncology.com
Publikováno v: Cancers. Nov2024, Vol. 16 Issue 21, p3642. 19p.
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