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. |
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| 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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| ISSN: | 1573-8744 |
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| DOI: | 10.1007/s10928-023-09850-2 |
