ReviewPharmaceutics2023
Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants-A Contribution from the ConcePTION Project.
Review in Pharmaceutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Pooled 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
- Anthropometric Exclusions in Pediatric Clinical Trials: Implications for Medication Dosing in Malnourished Children.Journal of clinical pharmacology · 2026Article
- Antiseizure Medication Dosing Strategy During Pregnancy and Early Postpartum in Women With Epilepsy in MONEAD.Neurology · 2026Observational
- 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
- 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
- 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
- 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
- EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.CPT: pharmacometrics & systems pharmacology · 2024Article
- Addressing health equity for breastfeeding women: primaquine for Plasmodium vivax radical cure.Malaria journal · 2024Review
- Defining the next generation of severe malaria treatment: a target product profile.Malaria journal · 2024Review
- Drugs in Human Milk Part 1: Practical and Analytical Considerations in Measuring Drugs and Metabolites in Human Milk.Clinical pharmacokinetics · 2024Review
- Article
- Very low monomethyl fumarate exposure via human milk: a case report-a contribution from the ConcePTION project.Frontiers in public health · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
Abstract
Physiologically based pharmacokinetic (PBPK) modelling is a bottom-up approach to predict pharmacokinetics in specific populations based on population-specific and medicine-specific data. Using an illustrative approach, this review aims to highlight the challenges of incorporating physiological data to develop postpartum, lactating women and breastfed infant PBPK models. For instance, most women retain pregnancy weight during the postpartum period, especially after excessive gestational weight gain, while breastfeeding might be associated with lower postpartum weight retention and long-term weight control. Based on a structured search, an equation for human milk intake reported the maximum intake of 153 mL/kg/day in exclusively breastfed infants at 20 days, which correlates with a high risk for medicine reactions at 2-4 weeks in breastfed infants. Furthermore, the changing composition of human milk and its enzymatic activities could affect pharmacokinetics in breastfed infants. Growth in breastfed infants is slower and gastric emptying faster than in formula-fed infants, while a slower maturation of specific metabolizing enzymes in breastfed infants has been described. The currently available PBPK models for these populations lack structured systematic acquisition of population-specific data. Future directions include systematic searches to fully identify physiological data. Following data integration as mathematical equations, this holds the promise to improve postpartum, lactation and infant PBPK models.
Indexed as
Identifiers
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.