Prediction of Maternal and Fetal Exposure to Escitalopram, Sertraline, and Paroxetine by Combining Human Ex Vivo Placenta Perfusion Data and Physiologically Based Pharmacokinetic Modeling

Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004;103:698–709.

Article  PubMed  Google Scholar 

Bérard A, Iessa N, Chaabane S, Muanda FT, Boukhris T, Zhao J-P. The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;81:589–604.

Article  PubMed  PubMed Central  Google Scholar 

Ibanez G, Charles M-A, Forhan A, Magnin G, Thiebaugeorges O, Kaminski M, et al. Depression and anxiety in women during pregnancy and neonatal outcome: data from the EDEN mother-child cohort. Early Hum Dev. 2012;88:643–9.

Article  PubMed  Google Scholar 

Bénard-Laribière A, Pambrun E, Sutter-Dallay A-L, Gautier S, Hurault-Delarue C, Damase-Michel C, et al. Patterns of antidepressant use during pregnancy: a nationwide population-based cohort study: patterns of antidepressant use in pregnancy. Br J Clin Pharmacol. 2018;84:1764–75.

Article  PubMed  PubMed Central  Google Scholar 

Cooper WO, Willy ME, Pont SJ, Ray WA. Increasing use of antidepressants in pregnancy. Am J Obstet Gynecol. 2007;196:544.e1-544.e5.

Article  PubMed  Google Scholar 

Treatment and management of mental health conditions during pregnancy and postpartum: ACOG clinical practice guideline no. 5. Obst Gynecol. 2023;141:1262–88.

Molenaar NM, Kamperman AM, Boyce P, Bergink V. Guidelines on treatment of perinatal depression with antidepressants: an international review. Aust N Z J Psychiatry. 2018;52:320–7.

Article  PubMed  PubMed Central  Google Scholar 

Louchet M, Tisseyre M, Kaguelidou F, Treluyer J-M, Préta L-H, Chouchana L. Drug-induced fetal and offspring disorders, beyond birth defects. Therapie. 2024;79:205–19.

Article  PubMed  Google Scholar 

Cohen LS. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499.

Article  CAS  PubMed  Google Scholar 

Pariente G, Leibson T, Carls A, Adams-Webber T, Ito S, Koren G. Pregnancy-associated changes in pharmacokinetics: a systematic review. PLoS Med. 2016;13:e1002160.

Article  PubMed  PubMed Central  Google Scholar 

Bouazza N, Foissac F, Hirt D, Urien S, Benaboud S, Lui G, et al. Methodological approaches to evaluate fetal drug exposure. Curr Pharm Des. 2019;25:496–504.

Article  CAS  PubMed  Google Scholar 

Coppola P, Kerwash E, Nooney J, Omran A, Cole S. Pharmacokinetic data in pregnancy: a review of available literature data and important considerations in collecting clinical data. Front Med (Lausanne). 2022;9:940644.

Article  PubMed  Google Scholar 

Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011;90:67–76.

Article  CAS  PubMed  Google Scholar 

Ke AB, Greupink R, Abduljalil K. Drug dosing in pregnant women: challenges and opportunities in using physiologically based pharmacokinetic modeling and simulations. CPT Pharmacom Syst Pharma. 2018;7:103–10.

Article  CAS  Google Scholar 

Abduljalil K, Badhan RKS. Drug dosing during pregnancy—opportunities for physiologically based pharmacokinetic models. J Pharmacokinet Pharmacodyn. 2020;47:319–40.

Article  PubMed  Google Scholar 

De Sousa Mendes M, Hirt D, Vinot C, Valade E, Lui G, Pressiat C, et al. Prediction of human fetal pharmacokinetics using ex vivo human placenta perfusion studies and physiologically based models. Br J Clin Pharmacol. 2016;81:646–57.

Article  PubMed  PubMed Central  Google Scholar 

Abduljalil K, Furness P, Johnson TN, Rostami-Hodjegan A, Soltani H. Anatomical, physiological and metabolic changes with gestational age during normal pregnancy: a database for parameters required in physiologically based pharmacokinetic modelling. Clin Pharmacokinet. 2012;51:365–96.

Article  CAS  PubMed  Google Scholar 

Abduljalil K, Pansari A, Jamei M. Prediction of maternal pharmacokinetics using physiologically based pharmacokinetic models: assessing the impact of the longitudinal changes in the activity of CYP1A2, CYP2D6 and CYP3A4 enzymes during pregnancy. J Pharmacokinet Pharmacodyn. 2020;47:361–83.

Article  CAS  PubMed  Google Scholar 

Abduljalil K, Gardner I, Jamei M. Application of a physiologically based pharmacokinetic approach to predict theophylline pharmacokinetics using virtual non-pregnant, pregnant, fetal, breast-feeding, and neonatal populations. Front Pediatr. 2022;10:840710.

Article  PubMed  PubMed Central  Google Scholar 

Abduljalil K, Jamei M, Johnson TN. Fetal physiologically based pharmacokinetic models: systems information on the growth and composition of fetal organs. Clin Pharmacokinet. 2019;58:235–62.

Article  CAS  PubMed  Google Scholar 

Abduljalil K, Jamei M, Johnson TN. Fetal physiologically based pharmacokinetic models: systems information on fetal blood components and binding proteins. Clin Pharmacokinet. 2020;59:629–42.

Article  CAS  PubMed  Google Scholar 

Abduljalil K, Pan X, Clayton R, Johnson TN, Jamei M. Fetal physiologically based pharmacokinetic models: systems information on fetal cardiac output and its distribution to different organs during development. Clin Pharmacokinet. 2021;60:741–57.

Article  PubMed  Google Scholar 

Préta L-H, Bouazza N, Foissac F, Froelicher L, Urien S, Dauvilliers A, et al. Comparison of human transplacental transfer of escitalopram, sertraline and paroxetine: an ex vivo cotyledon perfusion study. Placenta. 2025;168:150–8.

Article  PubMed  Google Scholar 

Roelofsen D, Van Hove H, Bukkems V, Russel F, Eliesen G, Greupink R. Predicting fetal exposure of crizotinib during pregnancy: combining human ex vivo placenta perfusion data with physiologically-based pharmacokinetic modeling. Toxicol In Vitro. 2022;85:105471.

Article  CAS  PubMed  Google Scholar 

Zhang Z, Guo Z, Tan Y, Li L, Wang Z, Wen Y, et al. Population pharmacokinetic approach to guide personalized sertraline treatment in Chinese patients. Heliyon. 2024;10:e25231.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Jamei M, Turner D, Yang J, Neuhoff S, Polak S, Rostami-Hodjegan A, et al. Population-based mechanistic prediction of oral drug absorption. AAPS J. 2009;11:225–37.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Templeton I, Chen Y, Mao J, Lin J, Yu H, Peters S, et al. Quantitative prediction of drug-drug interactions involving inhibitory metabolites in drug development: how can physiologically based pharmacokinetic modeling help? CPT Pharmacomet Syst Pharmacol. 2016;5:505–15.

Article  CAS  Google Scholar 

Rodgers T, Leahy D, Rowland M. Physiologically based pharmacokinetic modeling 1: predicting the tissue distribution of moderate-to-strong bases. J Pharm Sci. 2005;94:1259–76.

Article  CAS  PubMed  Google Scholar 

Yau E, Olivares-Morales A, Gertz M, Parrott N, Darwich AS, Aarons L, et al. Global sensitivity analysis of the Rodgers and Rowland model for prediction of tissue: plasma partitioning coefficients: assessment of the key physiological and physicochemical factors that determine small-molecule tissue distribution. AAPS J. 2020;22:41.

Article  PubMed  Google Scholar 

Steere B, Baker JAR, Hall SD, Guo Y. Prediction of in vivo clearance and associated variability of CYP2C19 substrates by genotypes in populations utilizing a pharmacogenetics-based mechanistic model. Drug Metab Dispos. 2015;43:870–83.

Article  CAS  PubMed  Google Scholar 

Zhou L, Sharma P, Yeo KR, Higashimori M, Xu H, Al-Huniti N, et al. Assessing pharmacokinetic differences in Caucasian and East Asian (Japanese, Chinese and Korean) populations driven by CYP2C19 polymorphism using physiologically-based pharmacokinetic modelling. Eur J Pharm Sci. 2019;139:105061.

Article  CAS  PubMed  Google Scholar 

Jornil J, Jensen KG, Larsen F, Linnet K. Identification of cytochrome P450 isoforms involved in the metabolism of paroxetine and estimation of their importance for human paroxetine metabolism using a population-based simulator. Drug Metab Dispos. 2010;38:376–85.

Article  CAS 

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