Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling-A Contribution from the ConcePTION Project.
breastfeeding
daily infant dosage
human milk
in silico
lactation
medicines
milk-to-plasma ratio (M/P ratio)
pharmacokinetics
physiologically-based pharmacokinetic (PBPK) modelling and simulation
relative infant dose
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
11 May 2023
11 May 2023
Historique:
received:
17
03
2023
revised:
28
04
2023
accepted:
03
05
2023
medline:
27
5
2023
pubmed:
27
5
2023
entrez:
27
5
2023
Statut:
epublish
Résumé
Women commonly take medication during lactation. Currently, there is little information about the exposure-related safety of maternal medicines for breastfed infants. The aim was to explore the performance of a generic physiologically-based pharmacokinetic (PBPK) model to predict concentrations in human milk for ten physiochemically diverse medicines. First, PBPK models were developed for "non-lactating" adult individuals in PK-Sim/MoBi v9.1 (Open Systems Pharmacology). The PBPK models predicted the area-under-the-curve (AUC) and maximum concentrations (C
Identifiants
pubmed: 37242712
pii: pharmaceutics15051469
doi: 10.3390/pharmaceutics15051469
pmc: PMC10223637
pii:
doi:
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Innovative Medicines Initiative
ID : 821520
Organisme : Research Foundation - Flanders
ID : 1S50721N
Références
Antivir Ther. 2013;18(4):585-90
pubmed: 23183881
Antimicrob Agents Chemother. 2009 Mar;53(3):1170-6
pubmed: 19114673
Clin Pharmacokinet. 2020 Nov;59(11):1419-1431
pubmed: 32449077
Biopharm Drug Dispos. 2022 Dec;43(6):221-232
pubmed: 36265038
J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Jan 5;766(1):175-9
pubmed: 11824394
Ther Drug Monit. 1984;6(3):272-6
pubmed: 6438834
Antivir Ther. 2012;17(8):1511-9
pubmed: 22910456
Drug Metab Dispos. 2010 May;38(5):833-40
pubmed: 20118196
Biomed Pharmacother. 2021 Apr;136:111038
pubmed: 33526310
J Clin Psychiatry. 2003 Jan;64(1):73-80
pubmed: 12590627
Clin Pharmacokinet. 1990 Feb;18(2):151-67
pubmed: 2318008
J Pharmacol Exp Ther. 1981 Dec;219(3):768-77
pubmed: 6795343
Clin Pharmacol Ther. 2022 May;111(5):1111-1120
pubmed: 35076931
J Infect Dis. 2005 Sep 1;192(5):720-7
pubmed: 16088821
Jpn J Psychiatry Neurol. 1988 Mar;42(1):89-96
pubmed: 3135429
Dev Pharmacol Ther. 1985;8(6):355-63
pubmed: 4075934
Arch Womens Ment Health. 2019 Jun;22(3):383-390
pubmed: 30116895
Antivir Ther. 2014;19(6):587-95
pubmed: 24464632
Acta Paediatr Scand. 1981;70(3):285-8
pubmed: 7246123
J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Aug 15;1060:300-307
pubmed: 28651173
Nucleic Acids Res. 2011 Jul;39(Web Server issue):W486-91
pubmed: 21576229
Animals (Basel). 2021 Mar 05;11(3):
pubmed: 33808012
Int J Pharm. 2013 Aug 16;452(1-2):8-13
pubmed: 22504091
J Chromatogr B Analyt Technol Biomed Life Sci. 2017 Jul 1;1057:101-109
pubmed: 28511118
Obstet Gynecol. 2005 Jun;105(6):1437-41
pubmed: 15932841
Clin Pharmacol Ther. 2003 Jan;73(1):71-7
pubmed: 12545145
Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0111021
pubmed: 34310204
Biopharm Drug Dispos. 2022 Oct;43(5):201-212
pubmed: 36209366
J Pharm Sci. 1987 Mar;76(3):189-93
pubmed: 3585733
Matern Child Nutr. 2020 Apr;16(2):e12938
pubmed: 31965755
CPT Pharmacometrics Syst Pharmacol. 2018 Jul;7(7):419-431
pubmed: 29569837
J Hum Lact. 2021 Feb;37(1):135-138
pubmed: 32853084
Pharmaceutics. 2021 Mar 17;13(3):
pubmed: 33802733
Am J Psychiatry. 1998 May;155(5):690-2
pubmed: 9585724
Arch Dis Child. 1979 Oct;54(10):787-9
pubmed: 507903
Br J Clin Pharmacol. 1998 May;45(5):453-7
pubmed: 9643617
Clin Pharmacol Ther. 1981 May;29(5):625-33
pubmed: 7214793
Br J Clin Pharmacol. 2022 Jan;88(1):199-205
pubmed: 34131926
Epilepsy Behav. 2019 Jun;95:112-116
pubmed: 31035102
CPT Pharmacometrics Syst Pharmacol. 2021 Aug;10(8):878-889
pubmed: 34213088
J Pharm Biomed Anal. 2016 Sep 10;129:502-508
pubmed: 27497651
J Matern Fetal Neonatal Med. 2023 Dec;36(1):2163626
pubmed: 36597824
Asia Pac J Public Health. 2016 Jan;28(1):7-14
pubmed: 26792873
Pharmacogenomics. 2016 Jun;17(8):891-906
pubmed: 27268507
Pharmacogenet Genomics. 2020 Feb;30(2):26-33
pubmed: 31851125
Ann Allergy Asthma Immunol. 2007 Apr;98(4):316-21
pubmed: 17458426
Biopharm Drug Dispos. 1988 May-Jun;9(3):285-99
pubmed: 3395670
J Anal Toxicol. 2016 Jul;40(6):473-7
pubmed: 27129353
J Clin Psychiatry. 2004 Sep;65(9):1228-34
pubmed: 15367050
Int Breastfeed J. 2015 Oct 28;10:28
pubmed: 26516340
J Antimicrob Chemother. 2015 Oct;70(10):2816-22
pubmed: 26108608
J Antimicrob Chemother. 2016 Apr;71(4):1027-30
pubmed: 26679247
Hum Psychopharmacol. 2000 Jun;15(4):161-264
pubmed: 12404316
Epilepsia. 2007 Jun;48(6):1111-6
pubmed: 17381438
Pediatrics. 2005 Feb;115(2):411-25
pubmed: 15687451
J Pharmacokinet Pharmacodyn. 2020 Aug;47(4):341-359
pubmed: 32748112
Epilepsia. 2005 May;46(5):775-7
pubmed: 15857447
J Matern Fetal Neonatal Med. 2019 Sep;32(18):3020-3025
pubmed: 29557689
Diabetologia. 2002 Nov;45(11):1509-14
pubmed: 12436333
Clin Infect Dis. 2007 Aug 1;45(3):391-4
pubmed: 17599320
Drug Metab Dispos. 2011 Dec;39(12):2370-80
pubmed: 21940904
Reprod Toxicol. 2015 Nov;57:204-6
pubmed: 26187779
J Antimicrob Chemother. 2018 Apr 1;73(4):1013-1019
pubmed: 29309634
PLoS Med. 2016 Sep 27;13(9):e1002132
pubmed: 27676257
CPT Pharmacometrics Syst Pharmacol. 2016 Oct;5(10):516-531
pubmed: 27653238
Am J Psychiatry. 2004 Jun;161(6):1066-78
pubmed: 15169695
J Acquir Immune Defic Syndr. 2007 Mar 1;44(3):286-91
pubmed: 17146372