State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development.
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
pubmed:
20
5
2018
medline:
28
2
2020
entrez:
20
5
2018
Statut:
ppublish
Résumé
Physiologically based pharmacokinetic modeling and simulation is an important tool for predicting the pharmacokinetics, pharmacodynamics, and safety of drugs in pediatrics. Physiologically based pharmacokinetic modeling is applied in pediatric drug development for first-time-in-pediatric dose selection, simulation-based trial design, correlation with target organ toxicities, risk assessment by investigating possible drug-drug interactions, real-time assessment of pharmacokinetic-safety relationships, and assessment of non-systemic biodistribution targets. This review summarizes the details of a physiologically based pharmacokinetic modeling approach in pediatric drug research, emphasizing reports on pediatric physiologically based pharmacokinetic models of individual drugs. We also compare and contrast the strategies employed by various researchers in pediatric physiologically based pharmacokinetic modeling and provide a comprehensive overview of physiologically based pharmacokinetic modeling strategies and approaches in pediatrics. We discuss the impact of physiologically based pharmacokinetic models on regulatory reviews and product labels in the field of pediatric pharmacotherapy. Additionally, we examine in detail the current limitations and future directions of physiologically based pharmacokinetic modeling in pediatrics with regard to the ability to predict plasma concentrations and pharmacokinetic parameters. Despite the skepticism and concern in the pediatric community about the reliability of physiologically based pharmacokinetic models, there is substantial evidence that pediatric physiologically based pharmacokinetic models have been used successfully to predict differences in pharmacokinetics between adults and children for several drugs. It is obvious that the use of physiologically based pharmacokinetic modeling to support various stages of pediatric drug development is highly attractive and will rapidly increase, provided the robustness and reliability of these techniques are well established.
Identifiants
pubmed: 29777528
doi: 10.1007/s40262-018-0677-y
pii: 10.1007/s40262-018-0677-y
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-13Références
AAPS J. 2013 Apr;15(2):455-64
pubmed: 23344790
AAPS PharmSci. 2000;2(1):E3
pubmed: 11741219
J Pharm Sci. 2018 Apr;107(4):1167-1177
pubmed: 29175411
J Pediatr Pharmacol Ther. 2014 Oct-Dec;19(4):262-76
pubmed: 25762871
Biopharm Drug Dispos. 2014 Sep;35(6):341-52
pubmed: 24797229
Drug Metab Dispos. 2016 Jul;44(7):934-43
pubmed: 26936973
Clin Pharmacol Ther. 2015 Sep;98(3):298-308
pubmed: 26073179
Regul Toxicol Pharmacol. 2003 Aug;38(1):1-16
pubmed: 12878049
CPT Pharmacometrics Syst Pharmacol. 2013 Oct 16;2:e80
pubmed: 24132164
J Biomed Biotechnol. 2011;2011:907461
pubmed: 21716673
CPT Pharmacometrics Syst Pharmacol. 2015 Feb;4(2):e17
pubmed: 26225230
J Toxicol Environ Health A. 2004 Feb 27;67(4):297-329
pubmed: 14713563
AAPS PharmSci. 2002;4(1):E4
pubmed: 12049488
Clin Pharmacokinet. 2006;45(10):1013-34
pubmed: 16984214
Pharm Res. 2016 Jan;33(1):52-71
pubmed: 26220249
Drug Metab Dispos. 2015 Nov;43(11):1823-37
pubmed: 26296709
Clin Pharmacokinet. 2006;45(7):683-704
pubmed: 16802850
CPT Pharmacometrics Syst Pharmacol. 2013 Aug 14;2:e63
pubmed: 23945604
J Pediatr. 2012 Apr;160(4):667-672.e2
pubmed: 22050870
Clin Pharmacol Ther. 2017 May;101(5):597-602
pubmed: 28074611
Clin Pharmacokinet. 2006;45(9):931-56
pubmed: 16928154
Biopharm Drug Dispos. 2015 May;36(4):245-57
pubmed: 25600493
Clin Infect Dis. 2011 Feb 1;52(3):285-92
pubmed: 21217178
Vasc Health Risk Manag. 2007;3(6):887-900
pubmed: 18200808
J Toxicol Environ Health A. 2003 Mar 14;66(5):417-33
pubmed: 12712630
Dtsch Arztebl Int. 2011 Oct;108(41):687-93
pubmed: 22114630
J Am Coll Cardiol. 2005 Aug 16;46(4):697-704
pubmed: 16098438
Clin Pharmacol Ther. 2012 Jul;92(1):40-9
pubmed: 22669290
Drug Metab Lett. 2015;9(2):80-7
pubmed: 26031462
J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):711-23
pubmed: 23179857
Ann ICRP. 2002;32(3-4):5-265
pubmed: 14506981
Pediatr Nephrol. 2009 Jan;24(1):67-76
pubmed: 18846389
Clin Pharmacol Ther. 2016 Dec;100(6):761-769
pubmed: 27530217
Clin Pharmacol Ther. 2014 Oct;96(4):429-37
pubmed: 24949994
Clin Pharmacokinet. 2014 Apr;53(4):327-46
pubmed: 24515100
Clin Pharmacokinet. 2013 Aug;52(8):693-703
pubmed: 23588537
CPT Pharmacometrics Syst Pharmacol. 2015 Apr;4(4):226-30
pubmed: 26225246
AAPS J. 2016 Nov;18(6):1453-1463
pubmed: 27450227
Clin Pharmacol Ther. 2012 May;91(5):926-31
pubmed: 22472993
Clin Pharmacokinet. 2002;41(13):1077-94
pubmed: 12403644
Pediatr Infect Dis J. 2003 Jun;22(6):504-9
pubmed: 12799506
Clin Pharmacol Ther. 2015 Mar;97(3):247-62
pubmed: 25670209
Am J Physiol. 1992 Mar;262(3 Pt 2):H903-10
pubmed: 1558199
Am J Psychiatry. 1996 Sep;153(9):1147-53
pubmed: 8780417
Paediatr Drugs. 2017 Apr;19(2):121-130
pubmed: 28078552
JAMA. 2000 Feb 23;283(8):1016-24
pubmed: 10697061
Drug Metab Dispos. 2017 Nov;45(11):1156-1165
pubmed: 28860113
Pediatrics. 2014 Aug;134(2):e562-3
pubmed: 25022746
Clin Pharmacol Ther. 2009 Dec;86(6):667-71
pubmed: 19847163
Clin Pharmacokinet. 2017 Nov;56(11):1343-1353
pubmed: 28290120
J Antimicrob Chemother. 1991 Apr;27(4):469-74
pubmed: 1856126
CPT Pharmacometrics Syst Pharmacol. 2016 Jul;5(7):367-76
pubmed: 27435752
Br J Clin Pharmacol. 2005 Jun;59(6):691-704
pubmed: 15948934
Drug Metab Dispos. 2017 Feb;45(2):216-223
pubmed: 27895113
Drug Metab Dispos. 2016 Jul;44(7):1080-9
pubmed: 26977099
Clin Pharmacokinet. 2018 May;57(5):577-589
pubmed: 28779462
CPT Pharmacometrics Syst Pharmacol. 2017 Feb;6(2):110-119
pubmed: 27935268
Clin Pharmacol Ther. 1986 Jan;39(1):72-81
pubmed: 3510796
CPT Pharmacometrics Syst Pharmacol. 2014 Oct 22;3:e150
pubmed: 25353188
Neonatology. 2014;105(4):344-9
pubmed: 24931327
N Engl J Med. 1991 Apr 11;324(15):1005-11
pubmed: 1848679
Paediatr Anaesth. 2011 Mar;21(3):291-301
pubmed: 20497354
Clin Ther. 2000;22 Suppl B:B101-121
pubmed: 10823378
J Pharmacokinet Pharmacodyn. 2012 Apr;39(2):195-203
pubmed: 22311388
Clin Pharmacol Ther. 2016 Oct;100(4):362-70
pubmed: 27301780
CPT Pharmacometrics Syst Pharmacol. 2012 Oct 03;1:e9
pubmed: 23887364
Pediatr Blood Cancer. 2011 Dec 1;57(6):1018-24
pubmed: 21445948
Paediatr Anaesth. 2011 Mar;21(3):206-13
pubmed: 21129100
Regul Toxicol Pharmacol. 2001 Feb;33(1):12-20
pubmed: 11259175
Pediatrics. 2010 Jun;125(6):e1294-300
pubmed: 20478934
Clin Pharmacokinet. 2011 Sep;50(9):613-23
pubmed: 21827216
Clin Pharmacol Ther. 2013 Feb;93(2):149
pubmed: 23187875
CPT Pharmacometrics Syst Pharmacol. 2017 May;6(5):315-321
pubmed: 28398693
J Am Acad Child Adolesc Psychiatry. 1993 Jul;32(4):792-7
pubmed: 8340300