Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Grimstein, M., Yang, Y., Zhang, X., Grillo, J., Huang, S. M., Zineh, I., & Wang, Y. J Pharm Sci, 108(1):21–25, January, 2019. doi abstract bibtex This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Limitations and knowledge gaps in integration of physiologically based pharmacokinetic approach to inform regulatory decision making, as well as the importance of scientific engagement with drug developers who intend to use this approach, are highlighted.
@article{grimstein_physiologically_2019,
title = {Physiologically {Based} {Pharmacokinetic} {Modeling} in {Regulatory} {Science}: {An} {Update} {From} the {U}.{S}. {Food} and {Drug} {Administration}'s {Office} of {Clinical} {Pharmacology}},
volume = {108},
issn = {1520-6017 (Electronic) 0022-3549 (Linking)},
doi = {10.1016/j.xphs.2018.10.033},
abstract = {This commentary provides an update on the status of physiologically based pharmacokinetic modeling and simulation at the U.S. Food and Drug Administration's Office of Clinical Pharmacology. Limitations and knowledge gaps in integration of physiologically based pharmacokinetic approach to inform regulatory decision making, as well as the importance of scientific engagement with drug developers who intend to use this approach, are highlighted.},
number = {1},
journal = {J Pharm Sci},
author = {Grimstein, M. and Yang, Y. and Zhang, X. and Grillo, J. and Huang, S. M. and Zineh, I. and Wang, Y.},
month = jan,
year = {2019},
keywords = {Computer Simulation/legislation \& jurisprudence, Humans, Models, Biological, Pharmaceutical Preparations/*standards, Pharmacokinetics, Pharmacology, Clinical/*legislation \& jurisprudence, United States, United States Food and Drug Administration/legislation \& jurisprudence, clinical pharmacokinetics, drug-drug interaction(s), in silico modeling, physiologically based pharmacokinetic (PBPK) modeling, regulatory science},
pages = {21--25},
}
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