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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.

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Title: FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
Authors: Shord SS; U.S. Food and Drug Administration, Silver Spring, Maryland., Chen C; Merck & Co., Inc., Rahway, New Jersey., Jin JY; Genentech, South San Francisco, California., Van Wart S; Enhanced Pharmacodynamics, Buffalo, New York., Martin SK; Eli Lilly and Company, Indianapolis, Indiana., Davidson BA; American Association for Cancer Research, Washington, District of Columbia., Liu J; U.S. Food and Drug Administration, Silver Spring, Maryland., LoRusso PM; Yale Cancer Center, New Haven, Connecticut., Oxnard GR; Eli Lilly and Company, Indianapolis, Indiana.
Source: Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2025 Dec 01; Vol. 31 (23), pp. 4891-4898.
Publication Type: Journal Article; Review
Journal Info: Publisher: American Association for Cancer Research Country of Publication: United States NLM ID: 9502500 Publication Model: Print Cited Medium: Internet ISSN: 1557-3265 (Electronic) Linking ISSN: 10780432 NLM ISO Abbreviation: Clin Cancer Res Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
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  Data: <searchLink fieldCode="AU" term="%22Shord+SS%22">Shord SS</searchLink>; U.S. Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22Chen+C%22">Chen C</searchLink>; Merck & Co., Inc., Rahway, New Jersey.<br /><searchLink fieldCode="AU" term="%22Jin+JY%22">Jin JY</searchLink>; Genentech, South San Francisco, California.<br /><searchLink fieldCode="AU" term="%22Van+Wart+S%22">Van Wart S</searchLink>; Enhanced Pharmacodynamics, Buffalo, New York.<br /><searchLink fieldCode="AU" term="%22Martin+SK%22">Martin SK</searchLink>; Eli Lilly and Company, Indianapolis, Indiana.<br /><searchLink fieldCode="AU" term="%22Davidson+BA%22">Davidson BA</searchLink>; American Association for Cancer Research, Washington, District of Columbia.<br /><searchLink fieldCode="AU" term="%22Liu+J%22">Liu J</searchLink>; U.S. Food and Drug Administration, Silver Spring, Maryland.<br /><searchLink fieldCode="AU" term="%22LoRusso+PM%22">LoRusso PM</searchLink>; Yale Cancer Center, New Haven, Connecticut.<br /><searchLink fieldCode="AU" term="%22Oxnard+GR%22">Oxnard GR</searchLink>; Eli Lilly and Company, Indianapolis, Indiana.
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  Data: <searchLink fieldCode="JN" term="%229502500%22">Clinical cancer research : an official journal of the American Association for Cancer Research</searchLink> [Clin Cancer Res] 2025 Dec 01; Vol. 31 (23), pp. 4891-4898.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Association+for+Cancer+Research%22">American Association for Cancer Research </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>9502500 <i>Publication Model: </i>Print <i>Cited Medium: </i>Internet <i>ISSN: </i>1557-3265 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210780432%22">10780432 </searchLink><i>NLM ISO Abbreviation: </i>Clin Cancer Res <i>Subsets: </i>MEDLINE
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        Value: 10.1158/1078-0432.CCR-25-0098
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      – Code: eng
        Text: English
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      – TitleFull: FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials.
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              Text: 2025 Dec 01
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              Y: 2025
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