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Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development
Authors:Yurong Lai  Xiaoyan Chu  Li Di  Wei Gao  Yingying Guo  Xingrong Liu  Chuang Lu  Jialin Mao  Hong Shen  Huaping Tang  Cindy Q. Xia  Lei Zhang  Xinxin Ding
Affiliation:1. Drug Metabolism, Gilead Sciences Inc., Foster City, CA 94404, USA;2. Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Inc., Kenilworth, NJ 07033, USA;3. Pharmacokinetics, Dynamics and Metabolism, Pfizer Worldwide Research and Development, Groton, CT 06340, USA;4. Eli Lilly and Company, Indianapolis, IN 46221, USA;5. Drug Metabolism and Pharmacokinetics, Biogen, Cambridge, MA 02142, USA;6. Drug Metabolism and Pharmacokinetics, Accent Therapeutics, Inc. Lexington, MA 02421, USA;7. Department of Drug Metabolism and Pharmacokinetics, Genentech, A Member of the Roche Group, South San Francisco, CA 94080, USA;8. Drug Metabolism and Pharmacokinetics Department, Bristol-Myers Squibb Company, Princeton, NJ 08540, USA;9. Bioanalysis and Biomarkers, Glaxo Smith Kline, King of the Prussia, PA 19406, USA;10. Department of Drug Metabolism and Pharmacokinetics, Takeda Pharmaceuticals International Co., Cambridge, MA 02139, USA;11. Office of Research and Standards, Office of Generic Drugs, CDER, FDA, Silver Spring, MD 20993, USA;12. Department of Pharmacology and Toxicology, College of Pharmacy, University of Arizona, Tucson, AZ 85721, USA
Abstract:
Keywords:Drug discovery and development  New drug application  Biologics license application  Pharmacokinetics  ADME  New modalities  Model-informed drug development  Micro-physiological systems
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