[1]
Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernández-Díaz S. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011; 205(1): 51.e1-8.
[2]
Daw JR, Hanley GE, Greyson DL, Morgan SG. Prescription drug use during pregnancy in developed countries: A systematic review. Pharmacoepidemiol Drug Saf 2011; 20(9): 895-902.
[3]
Vargesson N. Thalidomide-induced teratogenesis: History and mechanisms. Birth Defects Res C Embryo Today 2015; 105(2): 140-56.
[4]
Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med 1998; 338(16): 1128-37.
[5]
Wlodarczyk BJ, Palacios AM, George TM, Finnell RH. Antiepileptic drugs and pregnancy outcomes. Am J Med Genet A 2012; 158A(8): 2071-90.
[6]
Bode CJ, Jin H, Rytting E, Silverstein PS, Young AM, Audus KL. In vitro models for studying trophoblast transcellular transport. Methods Mol Med 2006; 122: 225-39.
[7]
Myllynen P, Vähäkangas K. Placental transfer and metabolism: An overview of the experimental models utilizing human placental tissue. Toxicol In Vitro 2013; 27(1): 507-12.
[8]
Prouillac C, Lecoeur S. The role of the placenta in fetal exposure to xenobiotics: importance of membrane transporters and human models for transfer studies. Drug Metab Dispos 2010; 38(10): 1623-35.
[9]
Liu F, Soares MJ, Audus KL. Permeability properties of monolayers of the human trophoblast cell line BeWo. Am J Physiol 1997; 273(5 Pt 1): C1596-604.
[10]
Evseenko DA, Paxton JW, Keelan JA. ABC drug transporter expression and functional activity in trophoblast-like cell lines and differentiating primary trophoblast. Am J Physiol Regul Integr Comp Physiol 2006; 290(5): R1357-65.
[11]
Amoroso EC. Histology of the placenta. Br Med Bull 1961; 17(2): 81-90.
[12]
Schmidt A, Morales-Prieto DM, Pastuschek J, Fröhlich K, Markert UR. Only humans have human placentas: molecular differences between mice and humans. J Reprod Immunol 2015; 108: 65-71.
[13]
Zhang Z, Imperial MZ, Patilea-Vrana GI, Wedagedera J, Gaohua L, Unadkat JD. Development of a novel maternal-fetal physiologically based pharmacokinetic model I: Insights into factors that determine fetal drug exposure through simulations and sensitivity analyses. Drug Metab Dispos 2017; 45(8): 920-38.
[14]
Gaynor LM, Colucci F. Uterine natural killer cells: Functional distinctions and influence on pregnancy in humans and mice. Front Immunol 2017; 8: 467.
[15]
Daud ANA, Bergman JEH, Oktora MP, et al. Maternal use of drug substrates of placental transporters and the effect of transporter-mediated drug interactions on the risk of congenital anomalies. PLoS One 2017; 12(3): e0173530.
[16]
Imperio GE, Javam M, Lye P, et al. Gestational age-dependent gene expression profiling of ATP-binding cassette transporters in the healthy human placenta. J Cell Mol Med 2019; 23(1): 610-8.
[17]
Soo JY, Wiese MD, Berry MJ, Morrison JL. Does poor fetal growth influence the extent of fetal exposure to maternal medications? Pharmacol Res 2018; 130: 74-84.
[18]
Tateishi T, Nakura H, Asoh M, et al. A comparison of hepatic cytochrome P450 protein expression between infancy and postinfancy. Life Sci 1997; 61(26): 2567-74.
[19]
Lacroix D, Sonnier M, Moncion A, Cheron G, Cresteil T. Expression of CYP3A in the human liver--evidence that the shift between CYP3A7 and CYP3A4 occurs immediately after birth. Eur J Biochem 1997; 247(2): 625-34.
[20]
Saghir SA, Khan SA, McCoy AT. Ontogeny of mammalian metabolizing enzymes in humans and animals used in toxicological studies. Crit Rev Toxicol 2012; 42(5): 323-57.
[21]
Hakkola J, Pelkonen O, Pasanen M, Raunio H. Xenobiotic-metabolizing cytochrome P450 enzymes in the human feto-placental unit: role in intrauterine toxicity. Crit Rev Toxicol 1998; 28(1): 35-72.
[22]
Pasanen M. The expression and regulation of drug metabolism in human placenta. Adv Drug Deliv Rev 1999; 38(1): 81-97.
[23]
Ejiri N, Katayama KI, Nakayama H, Doi K. Expression of cytochrome P450 (CYP) isozymes in rat placenta through pregnancy. Exp Toxicol Pathol 2001; 53(5): 387-91.
[24]
Stejskalova L, Vecerova L, Peréz LM, et al. Aryl hydrocarbon receptor and aryl hydrocarbon nuclear translocator expression in human and rat placentas and transcription activity in human trophoblast cultures. Toxicol Sci 2011; 123(1): 26-36.
[25]
Rubinchik-Stern M, Shmuel M, Bar J, Eyal S, Kovo M. Maternal-fetal transfer of indocyanine green across the perfused human placenta. Reprod Toxicol 2016; 62: 100-5.
[26]
Vinot C, Gavard L, Tréluyer JM, et al. Placental transfer of maraviroc in an ex vivo human cotyledon perfusion model and influence of ABC transporter expression. Antimicrob Agents Chemother 2013; 57(3): 1415-20.
[27]
Hill MD, Abramson FP. The significance of plasma protein binding on the fetal/maternal distribution of drugs at steady-state. Clin Pharmacokinet 1988; 14(3): 156-70.
[28]
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(1): 67-76.
[29]
Hirt D, Urien S, Jullien V, et al. Pharmacokinetic modelling of the placental transfer of nelfinavir and its M8 metabolite: A population study using 75 maternal-cord plasma samples. Br J Clin Pharmacol 2007; 64(5): 634-44.
[30]
Benaboud S, Ekouévi DK, Urien S, et al. Population pharmacokinetics of nevirapine in HIV-1-infected pregnant women and their neonates. Antimicrob Agents Chemother 2011; 55(1): 331-7.
[31]
Benaboud S, Tréluyer JM, Urien S, et al. Pregnancy-related effects on lamivudine pharmacokinetics in a population study with 228 women. Antimicrob Agents Chemother 2012; 56(2): 776-82.
[32]
Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Unadkat JD. Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19. Br J Clin Pharmacol 2014; 77(3): 554-70.
[33]
Alqahtani S, Kaddoumi A. Development of Physiologically Based Pharmacokinetic/Pharmacodynamic Model for Indomethacin Disposition in Pregnancy. PLoS One 2015; 10(10): e0139762.
[34]
Xia B, Heimbach T, Gollen R, Nanavati C, He H. A simplified PBPK modeling approach for prediction of pharmacokinetics of four primarily renally excreted and CYP3A metabolized compounds during pregnancy. AAPS J 2013; 15(4): 1012-24.
[35]
Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Unadkat JD. A PBPK Model to Predict Disposition of CYP3A-Metabolized Drugs in Pregnant Women: Verification and Discerning the Site of CYP3A Induction. CPT Pharmacometrics Syst Pharmacol 2012; 1: e3.
[36]
Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Isoherranen N, Unadkat JD. A physiologically based pharmacokinetic model to predict disposition of CYP2D6 and CYP1A2 metabolized drugs in pregnant women. Drug Metab Dispos 2013; 41(4): 801-13.
[37]
Gaohua L, Abduljalil K, Jamei M, Johnson TN, Rostami-Hodjegan A. A pregnancy physiologically based pharmacokinetic (p-PBPK) model for disposition of drugs metabolized by CYP1A2, CYP2D6 and CYP3A4. Br J Clin Pharmacol 2012; 74(5): 873-85.
[38]
Maruyama W, Yoshida K, Tanaka T, Nakanishi J. Simulation of dioxin accumulation in human tissues and analysis of reproductive risk. Chemosphere 2003; 53(4): 301-13.
[39]
Gargas ML, Tyler TR, Sweeney LM, et al. A toxicokinetic study of inhaled ethylene glycol monomethyl ether (2-ME) and validation of a physiologically based pharmacokinetic model for the pregnant rat and human. Toxicol Appl Pharmacol 2000; 165(1): 53-62.
[40]
Gentry PR, Covington TR, Andersen ME, Clewell HJ III. Application of a physiologically based pharmacokinetic model for isopropanol in the derivation of a reference dose and reference concentration. Regul Toxicol Pharmacol 2002; 36(1): 51-68.
[41]
Poet TS, Kirman CR, Bader M, van Thriel C, Gargas ML, Hinderliter PM. Quantitative risk analysis for N-methyl pyrrolidone using physiologically based pharmacokinetic and benchmark dose modeling. Toxicol Sci 2010; 113(2): 468-82.
[42]
Verner M-A, Ayotte P, Muckle G, Charbonneau M, Haddad S. A physiologically based pharmacokinetic model for the assessment of infant exposure to persistent organic pollutants in epidemiologic studies. Environ Health Perspect 2009; 117(3): 481-7.
[43]
Lumen A, Mattie DR, Fisher JW. Evaluation of perturbations in serum thyroid hormones during human pregnancy due to dietary iodide and perchlorate exposure using a biologically based dose-response model. Toxicol Sci 2013; 133(2): 320-41.
[44]
Verner M-A, Loccisano AE, Morken N-H, et al. Associations of Perfluoroalkyl Substances (PFAS) with Lower Birth Weight: An Evaluation of Potential Confounding by Glomerular Filtration Rate Using a Physiologically Based Pharmacokinetic Model (PBPK). Environ Health Perspect 2015; 123(12): 1317-24.
[45]
Loccisano AE, Longnecker MP, Campbell JL Jr, Andersen ME, Clewell HJ III. Development of PBPK models for PFOA and PFOS for human pregnancy and lactation life stages. J Toxicol Environ Health A 2013; 76(1): 25-57.
[46]
Lu G, Abduljalil K, Jamei M, Johnson TN, Soltani H, Rostami-Hodjegan A. Physiologically-based pharmacokinetic (PBPK) models for assessing the kinetics of xenobiotics during pregnancy: Achievements and shortcomings. Curr Drug Metab 2012; 13(6): 695-720.
[47]
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(2): 235-62.
[48]
Abduljalil K, Johnson TN, Rostami-Hodjegan A. Fetal Physiologically-Based Pharmacokinetic Models: Systems Information on Fetal Biometry and Gross Composition. Clin Pharmacokinet 2018; 57(9): 1149-71.
[49]
Zhang Z, Unadkat JD. Development of a Novel Maternal-Fetal Physiologically Based Pharmacokinetic Model II: Verification of the model for passive placental permeability drugs. Drug Metab Dispos 2017; 45(8): 939-46.
[50]
De Sousa Mendes M, Lui G, Zheng Y, et al. A physiologically-based pharmacokinetic model to predict human fetal exposure for a drug metabolized by several CYP450 pathways. Clin Pharmacokinet 2017; 56(5): 537-50.
[51]
De Sousa Mendes M, Hirt D, Vinot 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(4): 646-57.
[52]
Schalkwijk S, Buaben AO, Freriksen JJM, et al. Prediction of fetal darunavir exposure by integrating human ex-vivo placental transfer and physiologically based pharmacokinetic modeling. Clin Pharmacokinet 2018; 57(6): 705-16.
[53]
Unadkat JD, Dahlin A, Vijay S. Placental drug transporters. Curr Drug Metab 2004; 5(1): 125-31.
[54]
Sata R, Ohtani H, Tsujimoto M, et al. Functional analysis of organic cation transporter 3 expressed in human placenta. J Pharmacol Exp Ther 2005; 315(2): 888-95.