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A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.

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Title: A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.
Authors: Ruiz-Garcia A; Modeling and Simulation, Metrum Research Group, Tariffville, CT, USA. Ana.Ruiz5@gilead.com.; Clinical Pharmacology and Pharmacometrics, Gilead Sciences, Foster City, CA, USA. Ana.Ruiz5@gilead.com., Baverel P; Clinical Pharmacology, F. Hoffmann-La Roche AG, Basel, Switzerland.; Clinical Pharmacology and Clinical Biomarker, Molecular Partners, Schlieren, Switzerland., Bottino D; Oncology Modeling and Simulation, Takeda, Newton, MA, USA., Dolton M; Clinical Pharmacology, Genentech, South San Francisco, CA, USA., Feng Y; Clinical Pharmacology, Genmab, Copenhagen, Denmark., González-García I; Simulations Plus, Cognigen, Alicante, Spain., Kim J; Early Development Analytics, Novartis Institutes for BioMedical Research, Cambridge, MA, USA., Robey S; Quantitative Pharmacology and Pharmacometrics, Merck, Rahway, NJ, USA., Singh I; Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA., Turner D; Clinical Pharmacology, Genentech, South San Francisco, CA, USA., Wu SP; Clinical Pharmacology and Pharmacometrics, BioNTech SE, Boston, MA, USA., Yin D; Clinical Pharmacology, Early Oncology, Pfizer Inc., New York, NY, USA., Zhou D; Clinical Pharmacology, Modeling & Simulation, Amgen Inc., Thousand Oaks, CA, USA., Zhu H; Division of Pharmacometrics, Office of Clinical Pharmacology at FDA, Silver Spring, MD, USA., Bonate P; Clinical Pharmacology and Exploratory Development, Astellas, Northbrook, IL, USA.
Source: Journal of pharmacokinetics and pharmacodynamics [J Pharmacokinet Pharmacodyn] 2023 Jun; Vol. 50 (3), pp. 147-172. Date of Electronic Publication: 2023 Mar 04.
Publication Type: Journal Article; Review
Journal Info: Publisher: Springer Country of Publication: United States NLM ID: 101096520 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-8744 (Electronic) Linking ISSN: 1567567X NLM ISO Abbreviation: J Pharmacokinet Pharmacodyn Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.
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  Data: <searchLink fieldCode="AU" term="%22Ruiz-Garcia+A%22">Ruiz-Garcia A</searchLink>; Modeling and Simulation, Metrum Research Group, Tariffville, CT, USA. Ana.Ruiz5@gilead.com.; Clinical Pharmacology and Pharmacometrics, Gilead Sciences, Foster City, CA, USA. Ana.Ruiz5@gilead.com.<br /><searchLink fieldCode="AU" term="%22Baverel+P%22">Baverel P</searchLink>; Clinical Pharmacology, F. Hoffmann-La Roche AG, Basel, Switzerland.; Clinical Pharmacology and Clinical Biomarker, Molecular Partners, Schlieren, Switzerland.<br /><searchLink fieldCode="AU" term="%22Bottino+D%22">Bottino D</searchLink>; Oncology Modeling and Simulation, Takeda, Newton, MA, USA.<br /><searchLink fieldCode="AU" term="%22Dolton+M%22">Dolton M</searchLink>; Clinical Pharmacology, Genentech, South San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Feng+Y%22">Feng Y</searchLink>; Clinical Pharmacology, Genmab, Copenhagen, Denmark.<br /><searchLink fieldCode="AU" term="%22González-García+I%22">González-García I</searchLink>; Simulations Plus, Cognigen, Alicante, Spain.<br /><searchLink fieldCode="AU" term="%22Kim+J%22">Kim J</searchLink>; Early Development Analytics, Novartis Institutes for BioMedical Research, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Robey+S%22">Robey S</searchLink>; Quantitative Pharmacology and Pharmacometrics, Merck, Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Singh+I%22">Singh I</searchLink>; Clinical Pharmacology, Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Turner+D%22">Turner D</searchLink>; Clinical Pharmacology, Genentech, South San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Wu+SP%22">Wu SP</searchLink>; Clinical Pharmacology and Pharmacometrics, BioNTech SE, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Yin+D%22">Yin D</searchLink>; Clinical Pharmacology, Early Oncology, Pfizer Inc., New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Zhou+D%22">Zhou D</searchLink>; Clinical Pharmacology, Modeling & Simulation, Amgen Inc., Thousand Oaks, CA, USA.<br /><searchLink fieldCode="AU" term="%22Zhu+H%22">Zhu H</searchLink>; Division of Pharmacometrics, Office of Clinical Pharmacology at FDA, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Bonate+P%22">Bonate P</searchLink>; Clinical Pharmacology and Exploratory Development, Astellas, Northbrook, IL, USA.
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  Data: <searchLink fieldCode="JN" term="%22101096520%22">Journal of pharmacokinetics and pharmacodynamics</searchLink> [J Pharmacokinet Pharmacodyn] 2023 Jun; Vol. 50 (3), pp. 147-172. <i>Date of Electronic Publication: </i>2023 Mar 04.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Springer%22">Springer </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101096520 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1573-8744 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%221567567X%22">1567567X </searchLink><i>NLM ISO Abbreviation: </i>J Pharmacokinet Pharmacodyn <i>Subsets: </i>MEDLINE
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        Text: English
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              Text: 2023 Jun
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