Ito S. Mother and child: medication use in pregnancy and lactation. Clin Pharmacol Ther. 2016;100(1):8–11.
Article CAS PubMed Google Scholar
Alwan S, Bandoli G, Chambers CD. Maternal use of selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. Clin Pharmacol Ther. 2016;100(1):34–41.
Article CAS PubMed Google Scholar
Food U, Administration D. Clinical lactation studies: considerations for study design. Guidance for industry. Draft guidance. Silver Spring: Food and Drug Administration; 2019.
Yeung CHT, Ito S, Autmizguine J, Edginton AN. Incorporating breastfeeding-related variability with physiologically based pharmacokinetic modeling to predict infant exposure to maternal medication through breast milk: a workflow applied to lamotrigine. AAPS J. 2021;23(4):70.
Article CAS PubMed Google Scholar
Nauwelaerts N, Macente J, Deferm N, Bonan RH, Huang MC, Van Neste M, et al. Generic workflow to predict medicine concentrations in human milk using physiologically-based pharmacokinetic (PBPK) modelling—a contribution from the ConcePTION project. Pharmaceutics. 2023;15(5):1469.
Article CAS PubMed PubMed Central Google Scholar
Pansari A, Faisal M, Jamei M, Abduljalil K. Prediction of basic drug exposure in milk using a lactation model algorithm integrated within a physiologically based pharmacokinetic model. Biopharm Drug Dispos. 2022;43(5):201–12.
Article CAS PubMed Google Scholar
Weisskopf E, Guidi M, Fischer CJ, Bickle Graz M, Beaufils E, Nguyen KA, et al. A population pharmacokinetic model for escitalopram and its major metabolite in depressive patients during the perinatal period: prediction of infant drug exposure through breast milk. Br J Clin Pharmacol. 2020;86(8):1642–53.
Article CAS PubMed PubMed Central Google Scholar
Monfort A, Cardoso E, Eap CB, Fischer Fumeaux CJ, Graz MB, Morisod Harari M, et al. Infant exposure to fluvoxamine through placenta and human milk: a case series—a contribution from the ConcePTION project. Front Psychiatry. 2023;14:1167870.
Article PubMed PubMed Central Google Scholar
Chalifour B, Holzhausen EA, Lim JJ, Yeo EN, Shen N, Jones DP, et al. The potential role of early life feeding patterns in shaping the infant fecal metabolome: implications for neurodevelopmental outcomes. NPJ Metab Health Dis. 2023;1(1):2.
Article PubMed PubMed Central Google Scholar
Yeung CHT, Fong S, Malik PRV, Edginton AN. Quantifying breast milk intake by term and preterm infants for input into paediatric physiologically based pharmacokinetic models. Matern Child Nutr. 2020;16(2): e12938.
Article PubMed PubMed Central Google Scholar
Delaney SR, Malik PRV, Stefan C, Edginton AN, Colantonio DA, Ito S. Predicting escitalopram exposure to breastfeeding infants: integrating analytical and in silico techniques. Clin Pharmacokinet. 2018;57(12):1603–11.
Article CAS PubMed Google Scholar
Kent JC, Mitoulas LR, Cregan MD, Ramsay DT, Doherty DA, Hartmann PE. Volume and frequency of breastfeedings and fat content of breast milk throughout the day. Pediatrics. 2006;117(3):e387–95.
Mian P, Allegaert K, Conings S, Annaert P, Tibboel D, Pfister M, et al. Integration of placental transfer in a fetal-maternal physiologically based pharmacokinetic model to characterize acetaminophen exposure and metabolic clearance in the fetus. Clin Pharmacokinet. 2020;59(7):911–25.
Article CAS PubMed PubMed Central Google Scholar
Liu XI, Momper JD, Rakhmanina NY, Green DJ, Burckart GJ, Cressey TR, et al. Physiologically based pharmacokinetic modeling framework to predict neonatal pharmacokinetics of transplacentally acquired emtricitabine, dolutegravir, and raltegravir. Clin Pharmacokinet. 2021;60(6):795–809.
Article CAS PubMed PubMed Central Google Scholar
Pathirana J, Munoz FM, Abbing-Karahagopian V, Bhat N, Harris T, Kapoor A, et al. Neonatal death: case definition & guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2016;34(49):6027–37.
Article PubMed PubMed Central Google Scholar
Maharaj AR, Barrett JS, Edginton AN. A workflow example of PBPK modeling to support pediatric research and development: case study with lorazepam. AAPS J. 2013;15(2):455–64.
Article CAS PubMed PubMed Central Google Scholar
Maharaj AR, Edginton AN. Physiologically based pharmacokinetic modeling and simulation in pediatric drug development. CPT Pharmacometr Syst Pharmacol. 2014;3(11): e150.
Sinha J, Karatza E, Gonzalez D. Physiologically-based pharmacokinetic modeling of oxcarbazepine and levetiracetam during adjunctive antiepileptic therapy in children and adolescents. CPT Pharmacometr Syst Pharmacol. 2022;11(2):225–39.
Maglalang PD, Sinha J, Zimmerman K, McCann S, Edginton A, Hornik CP, et al. Application of physiologically based pharmacokinetic modeling to characterize the effects of age and obesity on the disposition of levetiracetam in the pediatric population. Clin Pharmacokinet. 2024;63(6):885–99.
Article CAS PubMed Google Scholar
Coupez R, Nicolas JM, Browne TR. Levetiracetam, a new antiepileptic agent: lack of in vitro and in vivo pharmacokinetic interaction with valproic acid. Epilepsia. 2003;44(2):171–8.
Article CAS PubMed Google Scholar
Review of environmental assessment for KEPPRA® oral solution (NDA 021‐505). October 31, 2002 ed; 2022.
Strolin Benedetti M, Whomsley R, Nicolas JM, Young C, Baltes E. Pharmacokinetics and metabolism of 14C-levetiracetam, a new antiepileptic agent, in healthy volunteers. Eur J Clin Pharmacol. 2003;59(8–9):621–30.
Article CAS PubMed Google Scholar
Salerno SN, Edginton A, Gerhart JG, Laughon MM, Ambalavanan N, Sokol GM, et al. Physiologically-based pharmacokinetic modeling characterizes the CYP3A-mediated drug-drug interaction between fluconazole and sildenafil in infants. Clin Pharmacol Ther. 2021;109(1):253–62.
Article CAS PubMed Google Scholar
Kacirova I, Grundmann M, Brozmanova H. Umbilical cord, maternal milk, and breastfed infant levetiracetam concentrations monitoring at delivery and during early postpartum period. Pharmaceutics. 2021;13(3):398.
Article CAS PubMed PubMed Central Google Scholar
Patsalos PN. Clinical pharmacokinetics of levetiracetam. Clin Pharmacokinet. 2004;43(11):707–24.
Article CAS PubMed Google Scholar
Yeung CHT, Autmizguine J, Dalvi P, Denoncourt A, Ito S, Katz P, et al. Maternal ezetimibe concentrations measured in breast milk and its use in breastfeeding infant exposure predictions. Clin Pharmacokinet. 2024;63(3):317–32.
Article CAS PubMed Google Scholar
Yeung CHT, Bertrand KA, Best BM, Capparelli E, Chambers CD, Hajducek DM, et al. Cannabidiol exposure through maternal marijuana use: predictions in breastfed infants. Clin Pharmacokinet. 2023;62(11):1611–9.
Article CAS PubMed PubMed Central Google Scholar
Dubinsky S, Malik P, Hajducek DM, Edginton A. Determining the effects of chronic kidney disease on organic anion transporter1/3 activity through physiologically based pharmacokinetic modeling. Clin Pharmacokinet. 2022;61(7):997–1012.
Article CAS PubMed Google Scholar
Johannessen SI, Helde G, Brodtkorb E. Levetiracetam concentrations in serum and in breast milk at birth and during lactation. Epilepsia. 2005;46(5):775–7.
Article CAS PubMed Google Scholar
Drugs and Lactation Database (LactMed®). 2006 2022 Nov 30 [cited 2023 July 24]. https://www.ncbi.nlm.nih.gov/books/NBK501229/.
Tomson T, Palm R, Kallen K, Ben-Menachem E, Soderfeldt B, Danielsson B, et al. Pharmacokinetics of levetiracetam during pregnancy, delivery, in the neonatal period, and lactation. Epilepsia. 2007;48(6):1111–6.
留言 (0)