3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration.
Autorzy:
Wang H; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, Maryland, USA. BrownPC; Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Chow ECY; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Ewart L; Emulate, Boston, Massachusetts, USA. Ferguson SS; Division of the National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA. Fitzpatrick S; Office of the Center Director, Center for Food Safety and Applied Nutrition, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Freedman BS; Division of Nephrology, Department of Pathology, Kidney Research Institute, and Institute for Stem Cell and Regenerative Medicine, University of Washington, Seattle, Washington, USA.; Department of Medicine, University of Washington, Seattle, Washington, USA. Guo GL; Department of Pharmacology and Toxicology, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, New Jersey, USA. Hedrich W; Pharmaceutical Candidate Optimization, Metabolism and Pharmacokinetics, Bristol-Myers Squibb Company, Princeton, New Jersey, USA. Heyward S; BioIVT, Halethorpe, Maryland, USA. Hickman J; NanoScience Technology Center, University of Central Florida, Orlando, Florida, USA. Isoherranen N; Department of Pharmaceutics, School of Pharmacy, University of Washington, Seattle, Washington, USA. Li AP; In Vitro ADMET Laboratories, Columbia, Maryland, USA.; In Vitro ADMET Laboratories, Malden, Massachusetts, USA. Liu Q; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Mumenthaler SM; Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, California, USA. Polli J; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, Maryland, USA. Proctor WR; Predictive Toxicology, Safety Assessment, Genentech, Inc, South San Francisco, California, USA. Ribeiro A; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Wang JY; Department of Surgery, Cell Biology Group, University of Maryland School of Medicine, Baltimore, Maryland, USA. Wange RL; Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Huang SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
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