ArticleCPT: pharmacometrics & systems pharmacology2024
Using PBPK modeling to supplement clinical data and support the safe and effective use of dolutegravir in pregnant and lactating women.
Article in CPT: pharmacometrics & systems pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Systematic Review of Published Physiologically Based Pharmacokinetic Models for Drug Excretion Into Human Breastmilk: Knowledge Gaps and Opportunities to Optimize Reporting and Modeling Practices.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- PBPK-Based Prediction of Oliceridine Exposure in Breast Milk and Relative Infant Dose During the First 24 h After Cesarean Delivery.Journal of clinical pharmacology · 2026Article
- PBPK Models for Fetal Drug Exposure: A Critical Assessment of Current Approaches and Regulatory Readiness.Journal of clinical pharmacology · 2026Review
- Physiologically-Based Pharmacokinetic Modeling to Investigate Piperaquine Exposure in Pregnant Women Using an Individualized Profile Approach.Clinical and translational science · 2026Article
- Application of Physiologically Based Pharmacokinetic Modeling in the Research of Anti-HIV Drugs.Current drug metabolism · 2025Review
- Pragmatic and contextualized methods selection for safety assessment of infant systemic exposure through human milk: the Milk4baby decision tree approach - a contribution from the concePTION project.Frontiers in pharmacology · 2025Article
- 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
- Recent applications of pharmacometrics and systems pharmacology approaches to improve and optimize drug therapy for pregnant and lactating women.CPT: pharmacometrics & systems pharmacology · 2024Article
- Review
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
Optimal dosing in pregnant and lactating women requires an understanding of the pharmacokinetics in the mother, fetus, and breastfed infant. Physiologically-based pharmacokinetic (PBPK) modeling can be used to simulate untested scenarios and hence supplement clinical data to support dosing decisions. A PBPK model for the antiretroviral dolutegravir (mainly metabolized by UGT1A1) was verified using reported exposures in non-pregnant healthy volunteers, pregnant women, and the umbilical cord, lactating mothers, and breastfed neonates. The model was then applied to predict the impact of UGT1A1 phenotypes in extensive (EM), poor (PM), and ultra-rapid metabolizers (UM). The predicted dolutegravir maternal plasma and umbilical cord AUC in UGT1A1 PMs was 1.6-fold higher than in EMs. The predicted dolutegravir maternal plasma and umbilical cord AUC in UGT1A1 UMs mothers was 1.3-fold lower than in EMs. The predicted mean systemic and umbilical vein concentrations were in excess of the dolutegravir IC
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