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Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products.

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Title: Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products.
Authors: Xiong Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Konicki R; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Zirkelbach JF; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Bi Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Okusanya O; Division of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Shord S; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Rahman NA; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Booth B; Division of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Li Y; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Liu J; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States., Zhu H; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
Source: The oncologist [Oncologist] 2026 May 08; Vol. 31 (6).
Publication Type: Journal Article; Review
Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Shifting a paradigm: highlights of model informed drug development in dosage selection and optimization for oncology products.
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  Data: <searchLink fieldCode="AU" term="%22Xiong+Y%22">Xiong Y</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Konicki+R%22">Konicki R</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Zirkelbach+JF%22">Zirkelbach JF</searchLink>; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Bi+Y%22">Bi Y</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Okusanya+O%22">Okusanya O</searchLink>; Division of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Shord+S%22">Shord S</searchLink>; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Rahman+NA%22">Rahman NA</searchLink>; Division of Cancer Pharmacology II, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Booth+B%22">Booth B</searchLink>; Division of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Li+Y%22">Li Y</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Liu+J%22">Liu J</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.<br /><searchLink fieldCode="AU" term="%22Zhu+H%22">Zhu H</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States.
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              Text: 2026 May 08
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