ArticlePharmaceutics2023
Generic Workflow to Predict Medicine Concentrations in Human Milk Using Physiologically-Based Pharmacokinetic (PBPK) Modelling-A Contribution from the ConcePTION Project.
Article in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Ketamine and esketamine during breastfeeding: a systematic review of human pharmacokinetic, infant and lactation outcomes.European journal of clinical pharmacology · 2026Pooled 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
- Physiologically Based Pharmacokinetic (PBPK) Modeling of Antidepressants: A Scoping Review of Existing Models, Applications, and Software Tools.Clinical pharmacokinetics · 2026Article
- Nonclinical Considerations for Support of Pregnancy and Lactation in Clinical Trials.Birth defects research · 2026Article
- Challenges during clinical lactation studies investigating medicines exposure: experiences from the UmbrelLACT study - a contribution from the ConcePTION project.BMJ paediatrics open · 2026Observational
- Application of Lactation Physiologically Based Pharmacokinetic Modeling to Predict Milk Exposure of Passively Diffused Drugs.Journal of clinical pharmacology · 2025Article
- Systematic Search of Height and Weight Changes of Exclusively Breastfed Infants Until 1 Year of age: A Contribution from the ConcePTION Project.Clinical pharmacokinetics · 2025Review
- Predicting Drug Transfer Into Human Milk With the Simcyp Simulator: A Contribution From the ConcePTION Project.CPT: pharmacometrics & systems pharmacology · 2025Article
- Population Pharmacokinetic Modeling of Amoxicillin in Plasma and Milk in Lactating Göttingen Minipigs - A Contribution from the ConcePTION Project.The AAPS journal · 2025Article
- Transporters and drug secretion into human breast milk.Expert opinion on drug metabolism & toxicology · 2025Review
- Postpartum changes in maternal physiology and milk composition: a comprehensive database for developing lactation physiologically-based pharmacokinetic models.Frontiers in pharmacology · 2025Article
- Clinical lactation studies. Acting on key recommendations over the last decade.npj women's health · 2025Review
- Clopidogrel transfer into human milk: case series - a contribution from the ConcePTION project.Frontiers in pharmacology · 2025Article
- Very low enalapril and enalaprilat exposureFrontiers in pharmacology · 2025Article
- Drug Safety During Breastfeeding: A Comparative Analysis of FDA Adverse Event Reports and LactMedPharmaceuticals (Basel, Switzerland) · 2024Article
- Coupling Pre- and Postnatal Infant Exposures with Physiologically Based Pharmacokinetic Modeling to Predict Cumulative Maternal Levetiracetam Exposure During Breastfeeding.Clinical pharmacokinetics · 2024Article
- Physiologically Based Pharmacokinetic Modeling to Assess the Impact of Pathophysiological Changes in Neonates: Strengths, Weaknesses, and Next Steps.Journal of clinical pharmacology · 2024Article
- Informing the risk assessment related to lactation and drug exposure: A physiologically based pharmacokinetic lactation model for pregabalin.CPT: pharmacometrics & systems pharmacology · 2024Article
- A close examination of BCRP's role in lactation and methods for predicting drug distribution into milk.CPT: pharmacometrics & systems pharmacology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
Women commonly take medication during lactation. Currently, there is little information about the exposure-related safety of maternal medicines for breastfed infants. The aim was to explore the performance of a generic physiologically-based pharmacokinetic (PBPK) model to predict concentrations in human milk for ten physiochemically diverse medicines. First, PBPK models were developed for "non-lactating" adult individuals in PK-Sim/MoBi v9.1 (Open Systems Pharmacology). The PBPK models predicted the area-under-the-curve (AUC) and maximum concentrations (C
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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.