Applied Concepts in PBPK Modeling: How to Extend an Open Systems Pharmacology Model to the Special Population of Pregnant Women

被引：45

作者：

Dallmann, Andre ^{[1
]}

Solodenko, Juri ^{[2
]}

Ince, Ibrahim ^{[2
]}

Eissing, Thomas ^{[2
]}

机构：

[1] Univ Childrens Hosp Basel UKBB, Dept Pediat Clin Pharmacol, Basel, Switzerland

[2] Bayer AG, Clin Pharmacometr, Leverkusen, Germany

来源：

CPT-PHARMACOMETRICS & SYSTEMS PHARMACOLOGY | 2018年 / 7卷 / 07期

关键词：

PHARMACOKINETIC MODEL; TISSUE DISTRIBUTION; DRUGS; METRONIDAZOLE; PREDICTION; PHYSIOLOGY; CODEINE;

D O I：

10.1002/psp4.12300

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

This tutorial presents the workflow of adapting an adult physiologically based pharmacokinetic (PBPK) model to the pregnant populations using the Open Systems Pharmacology (OSP) software suite (www.open-systems-pharmacology.org). This workflow is illustrated using a previously published PBPK model for metronidazole that is extrapolated to pregnancy by parameterizing and extending the model structure in terms of pregnancy-induced physiological changes. Importantly, this workflow can be applied to other scenarios where PBPK models need to be re-parameterized or structurally modified.

引用

页码：419 / 431

页数：13

共 38 条

[1]

Baeza-Squiban A., 2011, Nanoethics and Nanotoxicology, P63

[2] Development of a Physiologically-Based Pharmacokinetic Model for Preterm Neonates: Evaluation with In Vivo Data [J].

Claassen, Karina ;

Thelen, Kirstin ;

Coboeken, Katrin ;

Gaub, Thomas ;

Lippert, Joerg ;

Allegaert, Karel ;

Willmann, Stefan .

CURRENT PHARMACEUTICAL DESIGN, 2015, 21 (39) :5688-5698

[3] Physiologically Based Pharmacokinetic Modeling of Renally Cleared Drugs in Pregnant Women [J].

Dallmann, Andre ;

Ince, Ibrahim ;

Solodenko, Juri ;

Meyer, Michaela ;

Willmann, Stefan ;

Eissing, Thomas ;

Hempel, Georg .

CLINICAL PHARMACOKINETICS, 2017, 56 (12) :1525-1541

[4] Gestation-Specific Changes in the Anatomy and Physiology of Healthy Pregnant Women: An Extended Repository of Model Parameters for Physiologically Based Pharmacokinetic Modeling in Pregnancy [J].

Dallmann, Andre ;

Ince, Ibrahim ;

Meyer, Michaela ;

Willmann, Stefan ;

Eissing, Thomas ;

Hempel, Georg .

CLINICAL PHARMACOKINETICS, 2017, 56 (11) :1303-1330

[5] Physiologically based pharmacokinetic modeling of tamoxifen and its metabolites in women of different CYP2D6 phenotypes provides new insight into the tamoxifen mass balance [J].

Dickschen, Kristin ;

Willmann, Stefan ;

Thelen, Kirstin ;

Lippert, Joerg ;

Hempel, Georg ;

Eissing, Thomas .

FRONTIERS IN PHARMACOLOGY, 2012, 3

[6] Physiology-Based Simulations of a Pathological Condition Prediction of Pharmacokinetics in Patients with Liver Cirrhosis [J].

Edginton, Andrea N. ;

Willmann, Stefan .

CLINICAL PHARMACOKINETICS, 2008, 47 (11) :743-752

[7] Development and evaluation of a generic physiologically based pharmacokinetic model for children [J].

Edginton, Andrea N. ;

Schmitt, Walter ;

Willmann, Stefan .

CLINICAL PHARMACOKINETICS, 2006, 45 (10) :1013-1034

[8]

Eissing T, 2012, MOL DIAGN THER, V16, P43, DOI 10.2165/11597930-000000000-00000

[9] A computational systems biology software platform for multiscale modeling and simulation: integrating whole-body physiology, disease biology, and molecular reaction networks [J].

Eissing, Thomas ;

Kuepfer, Lars ;

Becker, Corina ;

Block, Michael ;

Coboeken, Katrin ;

Gaub, Thomas ;

Goerlitz, Linus ;

Jaeger, Juergen ;

Loosen, Roland ;

Ludewig, Bernd ;

Meyer, Michaela ;

Niederalt, Christoph ;

Sevestre, Michael ;

Siegmund, Hans-Ulrich ;

Solodenko, Juri ;

Thelen, Kirstin ;

Telle, Ulrich ;

Weiss, Wolfgang ;

Wendl, Thomas ;

Willmann, Stefan ;

Lippert, Joerg .

FRONTIERS IN PHYSIOLOGY, 2011, 2

[10]

European Medicines Agency, 2016, GUID QUAL REP PHYS B

← 1 2 3 4 →