The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.
Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review
Abstract
Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic (e.g., organ dysfunction, age, genetics) and extrinsic (e.g., drug-drug interactions) factors, alone or in combinations, on drug exposure. The use of this tool is increasing at all stages of the drug development process. This report reviews recent instances of the use of PBPK in decision-making during regulatory review. The examples are based on Center for Drug Evaluation and Research reviews of several submissions for investigational new drugs (INDs) and new drug applications (NDAs) received between July 2008 and June 2010. The use of PBPK modeling and simulation facilitated the following types of decisions: the need to conduct specific clinical pharmacology studies, specific study designs, and appropriate labeling language. The report also discusses the challenges encountered when PBPK modeling and simulation were used in these cases and recommends approaches to facilitating full utilization of this tool.
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Citations
Cites
Rodgers, T., Leahy, D., & Rowland, M. (2005) · Journal of Pharmaceutical Sciences · doi:10.1002/jps.20322 · Cited by 776
The Simcyp ® Population-based ADME Simulator
Jamei, M., Marciniak, S., Feng, K., Barnett, A., Tucker, G., & Rostami-Hodjegan, A. (2009) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1517/17425250802691074 · Cited by 533
Johnson, T. N., Rostami-Hodjegan, A., & Tucker, G. T. (2006) · Clinical Pharmacokinetics · doi:10.2165/00003088-200645090-00005 · Cited by 530
Development and Evaluation of a Generic Physiologically Based Pharmacokinetic Model for Children
Edginton, A. N., Schmitt, W., & Willmann, S. (2006) · Clinical Pharmacokinetics · doi:10.2165/00003088-200645100-00005 · Cited by 357
Cited by
Jones, H., Chen, Y., Gibson, C., Heimbach, T., Parrott, N., Peters, S., Snoeys, J., Upreti, V., Zheng, M., & Hall, S. (2015) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.37 · Cited by 488
Developmental Pharmacokinetics in Pediatric Populations
Lu, H., & Rosenbaum, S. (2014) · The Journal of Pediatric Pharmacology and Therapeutics · doi:10.5863/1551-6776-19.4.262 · Cited by 358
Rostami-Hodjegan, A. (2012) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2012.65 · Cited by 331
Organ-on-a-chip platforms: a convergence of advanced materials, cells, and microscale technologies
Ahadian, S., Civitarese, R., Bannerman, D., Mohammadi, M. H., Lu, R., Wang, E., Davenport‐Huyer, L., Lai, B., Zhang, B., Zhao, Y., et al. (2018) · Advanced Healthcare Materials · doi:10.1002/adhm.201700506 · Cited by 315
Jamei, M. (2016) · Current Pharmacology Reports · doi:10.1007/s40495-016-0059-9 · Cited by 244
Metadata
- Authors
- Zhao, P., Zhang, L., Grillo, J. A., Liu, Q., Bullock, J. M., Moon, Y. J., Song, P., Brar, S. S., Madabushi, R., Wu, T. C., Booth, B. P., Rahman, N. A., Reynolds, K. S., Gil Berglund, E., Lesko, L. J., & Huang, S.-M.
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2010-12-29
- Volume
- 89
- Issue
- 2
- Pages
- 259-267
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W2040233060
- Cited by
- 522
- References
- 4
- FWCI
- 27.76
- Type
- journal article
- Language
- en
- Open access
- closed
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