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857 results
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Physiologically-based pharmacokinetics in drug development and regulatory science.
Rowland M, Peck C, Tucker G. Rowland M, et al. Annu Rev Pharmacol Toxicol. 2011;51:45-73. doi: 10.1146/annurev-pharmtox-010510-100540. Annu Rev Pharmacol Toxicol. 2011. PMID: 20854171 Review.
Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.
Burt T, Yoshida K, Lappin G, Vuong L, John C, de Wildt SN, Sugiyama Y, Rowland M. Burt T, et al. Among authors: rowland m. Clin Transl Sci. 2016 Apr;9(2):74-88. doi: 10.1111/cts.12390. Epub 2016 Mar 30. Clin Transl Sci. 2016. PMID: 26918865 Free PMC article. Review.
Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions.
Zhao P, Rowland M, Huang SM. Zhao P, et al. Among authors: rowland m. Clin Pharmacol Ther. 2012 Jul;92(1):17-20. doi: 10.1038/clpt.2012.68. Clin Pharmacol Ther. 2012. PMID: 22713733
The role of physiologically based pharmacokinetic modeling in regulatory review.
Huang SM, Rowland M. Huang SM, et al. Among authors: rowland m. Clin Pharmacol Ther. 2012 Mar;91(3):542-9. doi: 10.1038/clpt.2011.320. Epub 2012 Feb 8. Clin Pharmacol Ther. 2012. PMID: 22318616
Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Lesko LJ, Rowland M, Peck CC, Blaschke TF. Lesko LJ, et al. Among authors: rowland m. J Clin Pharmacol. 2000 Aug;40(8):803-14. doi: 10.1177/00912700022009530. J Clin Pharmacol. 2000. PMID: 10934664
Microdosing: a critical assessment of human data.
Rowland M. Rowland M. J Pharm Sci. 2012 Nov;101(11):4067-74. doi: 10.1002/jps.23290. Epub 2012 Aug 23. J Pharm Sci. 2012. PMID: 22927093
Are Physiologically Based Pharmacokinetic Models Reporting the Right C(max)? Central Venous Versus Peripheral Sampling Site.
Musther H, Gill KL, Chetty M, Rostami-Hodjegan A, Rowland M, Jamei M. Musther H, et al. Among authors: rowland m. AAPS J. 2015 Sep;17(5):1268-79. doi: 10.1208/s12248-015-9796-7. Epub 2015 Jun 23. AAPS J. 2015. PMID: 26100012 Free PMC article.
Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, Peters SA, Reddy VP, Zheng M, de Zwart L, Beneton M, Bouzom F, Chen J, Chen Y, Cleary Y, Collins C, Dickinson GL, Djebli N, Einolf HJ, Gardner I, Huth F, Kazmi F, Khalil F, Lin J, Odinecs A, Patel C, Rong H, Schuck E, Sharma P, Wu SP, Xu Y, Yamazaki S, Yoshida K, Rowland M. Shebley M, et al. Among authors: rowland m. Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Clin Pharmacol Ther. 2018. PMID: 29315504 Free PMC article. Review.
Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products.
Cristofoletti R, Rowland M, Lesko LJ, Blume H, Rostami-Hodjegan A, Dressman JB. Cristofoletti R, et al. Among authors: rowland m. J Pharm Sci. 2018 Oct;107(10):2519-2530. doi: 10.1016/j.xphs.2018.06.013. Epub 2018 Jun 20. J Pharm Sci. 2018. PMID: 29935299
Lead PK commentary: predicting human pharmacokinetics.
Rowland M, Benet LZ. Rowland M, et al. J Pharm Sci. 2011 Oct;100(10):4047-9. doi: 10.1002/jps.22637. Epub 2011 May 31. J Pharm Sci. 2011. PMID: 21630278 No abstract available.
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