The In Silico Child: Using Simulation to Guide Pediatric Drug Development and Manage Pediatric Pharmacotherapy

作者: Stephanie Läer , Jeffrey S. Barrett , Bernd Meibohm

DOI: 10.1177/0091270009337513

关键词:

摘要: Significant gains have been made in the appreciation of pediatrics as an important population which rationale pharmacotherapy guidance is warranted but often currently lacking. Although regulatory framework for major improvements pediatric drug development was implemented Europe a decade later than United States, recent efforts, including 2007 "Better Medicines Children" initiative, indicate that awareness this problem indeed global phenomenon. Nevertheless, there still remains gap between and implementation scientifically based applied children. Specifically, vision how best to move from empiricism toward plan incorporates biologic knowledge about maturation physiologic processes well drug- disease-specific generated adults must evolve present intentions. Modeling simulation approaches can facilitate such ultimately should provide benefit patients. examples silico are compelling, their ultimate value may be identification data studies better guide therapy education caregivers principles clinical pharmacology underlie optimal pharmacotherapeutic decisions

参考文章(82)
Imti Choonara, Sharon Conroy, Unlicensed and off-label drug use in children: implications for safety. Drug Safety. ,vol. 25, pp. 1- 5 ,(2002) , 10.2165/00002018-200225010-00001
Jun Shi, Thomas M. Ludden, Armen P. Melikian, Marc R. Gastonguay, Peter H. Hinderling, Population pharmacokinetics and pharmacodynamics of sotalol in pediatric patients with supraventricular or ventricular tachyarrhythmia. Journal of Pharmacokinetics and Pharmacodynamics. ,vol. 28, pp. 555- 575 ,(2001) , 10.1023/A:1014412521191
Hartmut Derendorf, Bernd Meibohm, Modeling of pharmacokinetic/pharmacodynamic (PK/PD) relationships: concepts and perspectives. Pharmaceutical Research. ,vol. 16, pp. 176- 185 ,(1999) , 10.1023/A:1011907920641
V A Bhattaram, C Bonapace, D M Chilukuri, J Z Duan, C Garnett, J V S Gobburu, S H Jang, L Kenna, L J Lesko, R Madabushi, Y Men, J R Powell, W Qiu, R P Ramchandani, C W Tornoe, Y Wang, J J Zheng, Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006. Clinical Pharmacology & Therapeutics. ,vol. 81, pp. 213- 221 ,(2007) , 10.1038/SJ.CLPT.6100051
Liping Zhang, Vikram Sinha, S. Thomas Forgue, Sophie Callies, Lan Ni, Richard Peck, Sandra R. B. Allerheiligen, Model-based drug development: the road to quantitative pharmacology. Journal of Pharmacokinetics and Pharmacodynamics. ,vol. 33, pp. 369- 393 ,(2006) , 10.1007/S10928-006-9010-8
Jeffrey S Barrett, John T Mondick, Mahesh Narayan, Kalpana Vijayakumar, Sundararajan Vijayakumar, Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy. BMC Medical Informatics and Decision Making. ,vol. 8, pp. 6- 6 ,(2008) , 10.1186/1472-6947-8-6
Trevor N Johnson, Amin Rostami-Hodjegan, Geoffrey T Tucker, Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clinical Pharmacokinectics. ,vol. 45, pp. 931- 956 ,(2006) , 10.2165/00003088-200645090-00005
Harri Saxén, Kalle Hoppu, Maija Pohjavuori, Pharmacokinetics of fluconazole in very low birth weight infants during the first two weeks of life Clinical Pharmacology & Therapeutics. ,vol. 54, pp. 269- 277 ,(1993) , 10.1038/CLPT.1993.147