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Items: 10


Physiologically based pharmacokinetic modeling in regulatory decision-making at the European Medicines Agency.

Luzon E, Blake K, Cole S, Nordmark A, Versantvoort C, Berglund EG.

Clin Pharmacol Ther. 2017 Jul;102(1):98-105. doi: 10.1002/cpt.539. Epub 2016 Dec 26.


Towards quantitation of the effects of renal impairment and probenecid inhibition on kidney uptake and efflux transporters, using physiologically based pharmacokinetic modelling and simulations.

Hsu V, de L T Vieira M, Zhao P, Zhang L, Zheng JH, Nordmark A, Berglund EG, Giacomini KM, Huang SM.

Clin Pharmacokinet. 2014 Mar;53(3):283-293. doi: 10.1007/s40262-013-0117-y. Review.


Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug.

Vieira ML, Kirby B, Ragueneau-Majlessi I, Galetin A, Chien JY, Einolf HJ, Fahmi OA, Fischer V, Fretland A, Grime K, Hall SD, Higgs R, Plowchalk D, Riley R, Seibert E, Skordos K, Snoeys J, Venkatakrishnan K, Waterhouse T, Obach RS, Berglund EG, Zhang L, Zhao P, Reynolds KS, Huang SM.

Clin Pharmacol Ther. 2014 Feb;95(2):189-98. doi: 10.1038/clpt.2013.187. Epub 2013 Sep 18.


Transporter studies in drug development: experience to date and follow-up on decision trees from the International Transporter Consortium.

Tweedie D, Polli JW, Berglund EG, Huang SM, Zhang L, Poirier A, Chu X, Feng B; International Transporter Consortium.

Clin Pharmacol Ther. 2013 Jul;94(1):113-25. doi: 10.1038/clpt.2013.77. Epub 2013 Apr 10. Review.


The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use.

Pean E, Klaar S, Berglund EG, Salmonson T, Borregaard J, Hofland KF, Ersbøll J, Abadie E, Giuliani R, Pignatti F.

Clin Cancer Res. 2012 Sep 1;18(17):4491-7. doi: 10.1158/1078-0432.CCR-11-3075. Epub 2012 Jul 24.


Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor.

Vieira ML, Zhao P, Berglund EG, Reynolds KS, Zhang L, Lesko LJ, Huang SM.

Clin Pharmacol Ther. 2012 Apr;91(4):700-8. doi: 10.1038/clpt.2011.305. Epub 2012 Mar 7.


Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.

Grillo JA, Zhao P, Bullock J, Booth BP, Lu M, Robie-Suh K, Berglund EG, Pang KS, Rahman A, Zhang L, Lesko LJ, Huang SM.

Biopharm Drug Dispos. 2012 Mar;33(2):99-110. doi: 10.1002/bdd.1771. Epub 2012 Mar 4.


Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation.

Zhao P, Vieira Mde L, Grillo JA, Song P, Wu TC, Zheng JH, Arya V, Berglund EG, Atkinson AJ Jr, Sugiyama Y, Pang KS, Reynolds KS, Abernethy DR, Zhang L, Lesko LJ, Huang SM.

J Clin Pharmacol. 2012 Jan;52(1 Suppl):91S-108S. doi: 10.1177/0091270011415528.


AAPS workshop report: strategies to address therapeutic protein-drug interactions during clinical development.

Girish S, Martin SW, Peterson MC, Zhang LK, Zhao H, Balthasar J, Evers R, Zhou H, Zhu M, Klunk L, Han C, Berglund EG, Huang SM, Joshi A.

AAPS J. 2011 Sep;13(3):405-16. doi: 10.1208/s12248-011-9285-6. Epub 2011 Jun 1.


[The Medical Products Agency's preparations prior to the new EU regulation on children and drugs].

Johannesson M, Berglund EG.

Lakartidningen. 2007 Jul 11-24;104(28-29):2099. Swedish. No abstract available.


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