ReviewJournal of pharmacokinetics and pharmacodynamics2020
Clinical lactation studies and the role of pharmacokinetic modeling and simulation in predicting drug exposures in breastfed infants.
Review in Journal of pharmacokinetics and pharmacodynamics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06042803 (Clinical Lactation Study on the Exposure to Medicines Via Human Milk), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Efficacy and Safety of Antivirals in Lactating Women with Herpesviridae Infections: A Systematic Review.Viruses · 2025Pooled it
- Enabling pregnant women and their physicians to make informed medication decisions using artificial intelligence.Journal of pharmacokinetics and pharmacodynamics · 2020Pooled it
- Nonclinical Considerations for Support of Pregnancy and Lactation in Clinical Trials.Birth defects research · 2026Article
- Lack of Modulation of In Vivo Activity of Organic Anion Transporters 1 and 3 in Pregnancy Using Furosemide as a Probe.Journal of clinical pharmacology · 2026Article
- Breastmilk transfer and infant exposure to atazanavir/ritonavir in breastfeeding women with HIV: results from IMPAACT 2026.Frontiers in reproductive health · 2026Article
- Clinical study design and modeling approaches to study secretion of drugs in human milk.Frontiers in pediatrics · 2026Review
- PBPK-Led Assessment of Antimalarial Drug Concentrations in Breastmilk: A Strategy for Optimal Use of Prediction Methods to Guide Decision Making in an Understudied Population.CPT: pharmacometrics & systems pharmacology · 2025Article
- Clinical lactation studies. Acting on key recommendations over the last decade.npj women's health · 2025Review
- A literature review of drug transport mechanisms during lactation.CPT: pharmacometrics & systems pharmacology · 2024Review
- Informing the risk assessment related to lactation and drug exposure: A physiologically based pharmacokinetic lactation model for pregabalin.CPT: pharmacometrics & systems pharmacology · 2024Article
- Concentrations of remdesivir and GS-441524 in human milk from lactating individuals diagnosed with COVID-19.Pediatric research · 2024Article
- Selection of a suitable animal model to evaluate secretion of drugs in the human milk: a systematic approach.Xenobiotica; the fate of foreign compounds in biological systems · 2024Article
- Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol-a contribution from the ConcePTION project.BMJ paediatrics open · 2024Article
- Machine Learning Models for Prediction of Xenobiotic Chemicals with High Propensity to Transfer into Human Milk.ACS omega · 2024Article
- Supplementing clinical lactation studies with PBPK modeling to inform drug therapy in lactating mothers: Prediction of primaquine exposure as a case example.CPT: pharmacometrics & systems pharmacology · 2024Article
- Transfer of antibiotics and their metabolites in human milk: Implications for infant health and microbiota.Pharmacotherapy · 2023Review
- The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics.Pharmacotherapy · 2023Review
- Prediction model for milk transfer of drugs by primarily evaluating the area under the curve using QSAR/QSPR.Pharmaceutical research · 2023Article
- Addressing drug safety of maternal therapy during breastfeeding using physiologically-based pharmacokinetic modeling.CPT: pharmacometrics & systems pharmacology · 2022Article
- 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
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The relative lack of information on medication use during breastfeeding is an ongoing problem for health professionals and mothers alike. Most nursing mothers are prescribed some form of medication, yet some mothers either discontinue breastfeeding or avoid medications entirely. Although regulatory authorities have proposed a framework for clinical lactation studies, data on drug passage into breastmilk are often lacking. Model-based approaches can potentially be used to estimate the passage of drugs into milk, predict exposures in breastfed infants, and identify drugs that need clinical lactation studies. When a human study is called for, measurement of the drug concentration in milk are often adequate to characterize safety. Data from these studies can be leveraged to further refine pharmacokinetic models with subsequent Monte Carlo simulations to estimate the spread of exposure values. Both clinical lactation studies and model-based approaches have some limitations and pitfalls which are discussed.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.