Addressing Early Life Sensitivity Using Physiologically Based Pharmacokinetic Modeling and In Vitro to In Vivo Extrapolation
Physiologically based pharmacokinetic (PBPK) modeling can provide an effective way to utilize in vitro and in silico based information in modern risk assessment for children and other potentially sensitive populations. In this review, we describe the process of in vitro to in vivo extrapolation (IVI...
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| Published in | Toxicological research (Seoul) Vol. 32; no. 1; pp. 15 - 20 |
|---|---|
| Main Authors | , |
| Format | Journal Article |
| Language | English |
| Published |
Singapore
한국독성학회
01.01.2016
Springer Singapore Korean Society of Toxicology |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1976-8257 2234-2753 |
| DOI | 10.5487/TR.2016.32.1.015 |
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| Abstract | Physiologically based pharmacokinetic (PBPK) modeling can provide an effective way to utilize in vitro and in silico based information in modern risk assessment for children and other potentially sensitive populations. In this review, we describe the process of in vitro to in vivo extrapolation (IVIVE) to develop PBPK models for a chemical in different ages in order to predict the target tissue exposure at the age of concern in humans. We present our on-going studies on pyrethroids as a proof of concept to guide the readers through the IVIVE steps using the metabolism data collected either from age-specific liver donors or expressed enzymes in conjunction with enzyme ontogeny information to provide age-appropriate metabolism parameters in the PBPK model in the rat and human, respectively. The approach we present here is readily applicable to not just to other pyrethroids, but also to other environmental chemicals and drugs. Establishment of an in vitro and in silico-based evaluation strategy in conjunction with relevant exposure information in humans is of great importance in risk assessment for potentially vulnerable populations like early ages where the necessary information for decision making is limited. |
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| AbstractList | Physiologically based pharmacokinetic (PBPK) modeling can provide an effective way to utilize in vitro and in silico based information in modern risk assessment for children and other potentially sensitive populations. In this review, we describe the process of in vitro to in vivo extrapolation (IVIVE) to develop PBPK models for a chemical in different ages in order to predict the target tissue exposure at the age of concern in humans. We present our on-going studies on pyrethroids as a proof of concept to guide the readers through the IVIVE steps using the metabolism data collected either from age-specific liver donors or expressed enzymes in conjunction with enzyme ontogeny information to provide age-appropriate metabolism parameters in the PBPK model in the rat and human, respectively. The approach we present here is readily applicable to not just to other pyrethroids, but also to other environmental chemicals and drugs. Establishment of an in vitro and in silico-based evaluation strategy in conjunction with relevant exposure information in humans is of great importance in risk assessment for potentially vulnerable populations like early ages where the necessary information for decision making is limited. Physiologically based pharmacokinetic (PBPK) modeling can provide an effective way to utilize in vitro and in silico based information in modern risk assessment for children and other potentially sensitive populations. In this review, we describe the process of in vitro to in vivo extrapolation (IVIVE) to develop PBPK models for a chemical in different ages in order to predict the target tissue exposure at the age of concern in humans. We present our on-going studies on pyrethroids as a proof of concept to guide the readers through the IVIVE steps using the metabolism data collected either from age-specific liver donors or expressed enzymes in conjunction with enzyme ontogeny information to provide age-appropriate metabolism parameters in the PBPK model in the rat and human, respectively. The approach we present here is readily applicable to not just to other pyrethroids, but also to other environmental chemicals and drugs. Establishment of an in vitro and in silico-based evaluation strategy in conjunction with relevant exposure information in humans is of great importance in risk assessment for potentially vulnerable populations like early ages where the necessary information for decision making is limited. KCI Citation Count: 1 |
| Author | Miyoung Yoon Harvey J. Clewell, III |
| Author_xml | – sequence: 1 givenname: Miyoung surname: Yoon fullname: Yoon, Miyoung email: myoon@scitovation.com organization: The Hamner Institutes for Health Sciences – sequence: 2 givenname: Harvey J. surname: Clewell fullname: Clewell, Harvey J. organization: The Hamner Institutes for Health Sciences |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26977255$$D View this record in MEDLINE/PubMed https://www.kci.go.kr/kciportal/ci/sereArticleSearch/ciSereArtiView.kci?sereArticleSearchBean.artiId=ART002075222$$DAccess content in National Research Foundation of Korea (NRF) |
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| CitedBy_id | crossref_primary_10_1016_j_comtox_2019_100101 crossref_primary_10_1007_s10928_016_9492_y crossref_primary_10_1016_j_comtox_2019_100115 crossref_primary_10_5487_TR_2016_32_1_001 crossref_primary_10_3390_pharmaceutics12100975 crossref_primary_10_1093_toxsci_kfaa070 crossref_primary_10_1093_toxsci_kfy236 crossref_primary_10_1007_s00204_017_2126_3 crossref_primary_10_1093_toxsci_kfz211 crossref_primary_10_1093_toxsci_kfy010 crossref_primary_10_1016_j_taap_2023_116651 crossref_primary_10_1016_j_fct_2024_114789 |
| Cites_doi | 10.1016/j.envint.2015.05.006 10.1016/j.tox.2010.12.010 10.1093/toxsci/kfq074 10.1016/0300-483X(96)03385-9 10.1016/j.taap.2005.12.001 10.1177/074823379701300401 10.1016/j.tox.2014.05.006 10.1080/20024091064264 10.1006/taap.1994.1106 10.1021/tx100428e 10.1016/j.yrtph.2011.06.004 10.1016/j.bcp.2005.11.020 10.1038/nrd2173 10.1093/toxsci/kfu169 10.1016/j.taap.2007.03.002 10.1002/etc.34 10.2174/138920008786485164 10.1016/j.tox.2013.08.012 10.2165/00003088-200645090-00005 10.1517/17425250802691074 10.3109/10408444.2012.692115 10.1016/j.bcp.2008.10.005 10.1016/j.taap.2009.12.034 10.1186/2193-9616-1-9 10.1146/annurev-pharmtox-010510-100540 10.1093/toxsci/kfh109 10.1002/jbt.20179 10.3109/10408444.2012.674100 10.1093/toxsci/kfl056 10.1016/j.pharmthera.2008.02.005 10.1016/0378-4274(93)90123-F 10.1124/dmd.106.010058 10.1124/dmd.105.007807 10.1016/j.taap.2008.04.021 10.1016/j.yrtph.2005.01.004 10.1093/toxsci/kfq188 10.3389/fphar.2014.00246 10.1080/10408440390242324 10.1016/j.yrtph.2011.05.009 |
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| Keywords | PBPK Ontogeny Early life sensitivity IVIVE |
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| Title | Addressing Early Life Sensitivity Using Physiologically Based Pharmacokinetic Modeling and In Vitro to In Vivo Extrapolation |
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