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Items: 1 to 20 of 96

1.

Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.

Zhao P, Zhang L, Grillo JA, Liu Q, Bullock JM, Moon YJ, Song P, Brar SS, Madabushi R, Wu TC, Booth BP, Rahman NA, Reynolds KS, Gil Berglund E, Lesko LJ, Huang SM.

Clin Pharmacol Ther. 2011 Feb;89(2):259-67. doi: 10.1038/clpt.2010.298. Epub 2010 Dec 29.

PMID:
21191381
2.

Physiologically based pharmacokinetic (PBPK) modeling and simulation: applications in lead optimization.

Peters SA, Ungell AL, Dolgos H.

Curr Opin Drug Discov Devel. 2009 Jul;12(4):509-18. Review.

PMID:
19562647
3.

Physiologically based pharmacokinetic (PBPK) modeling in children.

Barrett JS, Della Casa Alberighi O, Läer S, Meibohm B.

Clin Pharmacol Ther. 2012 Jul;92(1):40-9. doi: 10.1038/clpt.2012.64. Epub 2012 Jun 6. Review.

PMID:
22669290
4.

Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications.

Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, Duan JZ, Baweja RK, Marroum PJ, Uppoor RS, Rahman NA, Sahajwalla CG, Powell JR, Mehta MU, Gobburu JV.

AAPS J. 2005 Oct 7;7(3):E503-12. Review.

5.

Physiologically based pharmacokinetics (PBPK).

Espié P, Tytgat D, Sargentini-Maier ML, Poggesi I, Watelet JB.

Drug Metab Rev. 2009;41(3):391-407. doi: 10.1080/10837450902891360. Review.

PMID:
19601719
6.

Physiologically based pharmacokinetics joined with in vitro-in vivo extrapolation of ADME: a marriage under the arch of systems pharmacology.

Rostami-Hodjegan A.

Clin Pharmacol Ther. 2012 Jul;92(1):50-61. doi: 10.1038/clpt.2012.65. Epub 2012 May 30. Review.

PMID:
22644330
7.
8.

Physiologically-based pharmacokinetics in drug development and regulatory science.

Rowland M, Peck C, Tucker G.

Annu Rev Pharmacol Toxicol. 2011;51:45-73. doi: 10.1146/annurev-pharmtox-010510-100540. Review.

PMID:
20854171
9.

Whole body physiologically-based pharmacokinetic models: their use in clinical drug development.

Edginton AN, Theil FP, Schmitt W, Willmann S.

Expert Opin Drug Metab Toxicol. 2008 Sep;4(9):1143-52. doi: 10.1517/17425255.4.9.1143 . Review.

PMID:
18721109
10.

Physiologically based pharmacokinetic modeling of nanoparticles.

Li M, Al-Jamal KT, Kostarelos K, Reineke J.

ACS Nano. 2010 Nov 23;4(11):6303-17. doi: 10.1021/nn1018818. Epub 2010 Oct 14. Review.

PMID:
20945925
11.

The utility of modeling and simulation in drug development and regulatory review.

Huang SM, Abernethy DR, Wang Y, Zhao P, Zineh I.

J Pharm Sci. 2013 Sep;102(9):2912-23. doi: 10.1002/jps.23570. Epub 2013 May 24. Review.

PMID:
23712632
12.

Role of modeling and simulation in pediatric investigation plans.

Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, Saint Raymond A.

Paediatr Anaesth. 2011 Mar;21(3):214-21. doi: 10.1111/j.1460-9592.2011.03523.x. Epub 2011 Jan 18. Review.

PMID:
21244569
13.

Impact of physiologically based pharmacokinetic models on regulatory reviews and product labels: Frequent utilization in the field of oncology.

Yoshida K, Budha N, Jin JY.

Clin Pharmacol Ther. 2017 May;101(5):597-602. doi: 10.1002/cpt.622. Epub 2017 Mar 15. Review.

14.

Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification.

Sager JE, Yu J, Ragueneau-Majlessi I, Isoherranen N.

Drug Metab Dispos. 2015 Nov;43(11):1823-37. doi: 10.1124/dmd.115.065920. Epub 2015 Aug 21. Review.

15.

Predicting drug-drug interactions: an FDA perspective.

Zhang L, Zhang YD, Zhao P, Huang SM.

AAPS J. 2009 Jun;11(2):300-6. doi: 10.1208/s12248-009-9106-3. Epub 2009 May 6. Review.

16.

Physiologically based pharmacokinetic modeling: methodology, applications, and limitations with a focus on its role in pediatric drug development.

Khalil F, Läer S.

J Biomed Biotechnol. 2011;2011:907461. doi: 10.1155/2011/907461. Epub 2011 Jun 1. Review.

17.

Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.

Harapanhalli RS.

Semin Nucl Med. 2010 Sep;40(5):364-84. doi: 10.1053/j.semnuclmed.2010.05.002. Review.

PMID:
20674596
18.

Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives.

Ibrahim S, Honig P, Huang SM, Gillespie W, Lesko LJ, Williams RL.

J Clin Pharmacol. 2000 Jan;40(1):31-8. Review.

PMID:
10631619
19.

A regulatory viewpoint on transporter-based drug interactions.

Zhang L, Zhang YD, Strong JM, Reynolds KS, Huang SM.

Xenobiotica. 2008 Jul;38(7-8):709-24. doi: 10.1080/00498250802017715 . Review.

PMID:
18668428
20.

Pharmacometrics at FDA: evolution and impact on decisions.

Powell JR, Gobburu JV.

Clin Pharmacol Ther. 2007 Jul;82(1):97-102. Epub 2007 May 30. Review.

PMID:
17538553

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