ArticleClinical pharmacokinetics2022
Prediction of Maternal and Fetal Acyclovir, Emtricitabine, Lamivudine, and Metformin Concentrations during Pregnancy Using a Physiologically Based Pharmacokinetic Modeling Approach.
Article in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- PBPK Models for Fetal Drug Exposure: A Critical Assessment of Current Approaches and Regulatory Readiness.Journal of clinical pharmacology · 2026Review
- Comparison of Metformin PBPK Models Incorporating Placental Transfer to Predict Fetal and Maternal Exposure.CPT: pharmacometrics & systems pharmacology · 2026Article
- Application of a Physiologically Based Pharmacokinetic Approach to Predict Tenofovir Pharmacokinetics During Pregnancy.The AAPS journal · 2025Article
- Physiologically based pharmacokinetic modeling of small molecules: How much progress have we made?Drug metabolism and disposition: the biological fate of chemicals · 2025Review
- Application of Physiologically Based Pharmacokinetic Modeling in the Research of Anti-HIV Drugs.Current drug metabolism · 2025Review
- Strategy advancements in placental pharmacokinetics: fromFrontiers in pharmacology · 2025Review
- Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women.CPT: pharmacometrics & systems pharmacology · 2024Article
- Review
- Evaluation of Various Approaches to Estimate Transplacental Clearance of Vancomycin for Predicting Fetal Concentrations using a Maternal-Fetal Physiologically Based Pharmacokinetic Model.Pharmaceutical research · 2024Article
- An Application of a Physiologically Based Pharmacokinetic Approach to Predict Ceftazidime Pharmacokinetics in a Pregnant Population.Pharmaceutics · 2024Article
- An update on placental drug transport and its relevance to fetal drug exposure.Medical review (2021) · 2022Review
- Application of a Physiologically Based Pharmacokinetic Approach to Predict Theophylline Pharmacokinetics Using Virtual Non-Pregnant, Pregnant, Fetal, Breast-Feeding, and Neonatal Populations.Frontiers in pediatrics · 2022Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundConcerns over maternal and fetal drug exposure during pregnancy highlight the need for improved understanding of drug distribution to the fetus through the placental barrier.
objectiveOur objective was to predict maternal and fetal drug disposition using a physiologically based pharmacokinetic (PBPK) modeling approach.
methodsWe used the detailed maternal-placental-fetal PBPK model within the Simcyp Simulator V20 to predict the maternal and fetal drug exposure of acyclovir, emtricitabine, lamivudine, and metformin during pregnancy and at delivery. The dynamic model includes gestational changes to the maternal, fetal, and placental physiological parameters. Placental kinetics were parameterized using published ex vivo data for these four compounds. Amniotic data were included where available. PBPK predictions were compared with the observed data using twofold criteria.
resultsMaternal-fetal PBPK models were developed completely from the bottom up without any parameter adjustments. The PBPK model-predicted exposures matched the observed maternal and umbilical exposure for acyclovir (six maternal studies, all of which all reported umbilical exposure), emtricitabine (six maternal studies, of which four reported umbilical exposure), lamivudine, (five maternal studies, of which four reported umbilical exposure), and metformin (seven studies, of which six reported umbilical exposure). Predicted pharmacokinetic parameters were within twofold of the observed values.
conclusionIntegration of fetal and maternal system parameters within PBPK models, together with experimental data from ex vivo placental perfusion studies, facilitated and extended the application of the pregnancy PBPK model. Such models can also be used inform clinical trials and maternal/fetal risk assessment following maternally administered drugs or unintended exposure to environmental toxicants.
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Registered trials
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