ArticleBritish journal of clinical pharmacology2014
Population PK modelling and simulation based on fluoxetine and norfluoxetine concentrations in milk: a milk concentration-based prediction model.
Article in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed, 21 citations in OpenAlex.
- Pharmacokinetics of Transfer of Azithromycin into the Breast Milk of African Mothers.Antimicrobial agents and chemotherapy · 2015Trial
- Rules of Thumb for Estimating Drug Levels in Breast Milk: How Well Do They Work?Clinical pharmacology and therapeutics · 2026Article
- Clinical study design and modeling approaches to study secretion of drugs in human milk.Frontiers in pediatrics · 2026Review
- Bridging Literature and Real-World Evidence: External Evaluation and Development of Fluoxetine Population Pharmacokinetics Model.Pharmaceutics · 2025Article
- Population pharmacokinetic modelling of cetirizine concentrations in human breast milk-A contribution from the ConcePTION project.Basic & clinical pharmacology & toxicology · 2025Article
- Allopregnanolone Concentrations in Breast Milk and Plasma from Healthy Volunteers Receiving Brexanolone Injection, With Population Pharmacokinetic Modeling of Potential Relative Infant Dose.Clinical pharmacokinetics · 2022Article
- The value of midwifery counseling during lactation as a key factor of pharmacovigilance.European journal of midwifery · 2022Article
- Clinical lactation studies and the role of pharmacokinetic modeling and simulation in predicting drug exposures in breastfed infants.Journal of pharmacokinetics and pharmacodynamics · 2020Review
- Predicting Escitalopram Exposure to Breastfeeding Infants: Integrating Analytical and In Silico Techniques.Clinical pharmacokinetics · 2018Article
- Drugs in Lactation.Pharmaceutical research · 2018Review
Corrections and comments
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Authors and funding
9 authors at 7 institutions in 5 countries.
Funding
Abstract
aimsPopulation pharmacokinetic (pop PK) modelling can be used for PK assessment of drugs in breast milk. However, complex mechanistic modelling of a parent and an active metabolite using both blood and milk samples is challenging. We aimed to develop a simple predictive pop PK model for milk concentration-time profiles of a parent and a metabolite, using data on fluoxetine (FX) and its active metabolite, norfluoxetine (NFX), in milk.
methodsUsing a previously published data set of drug concentrations in milk from 25 women treated with FX, a pop PK model predictive of milk concentration-time profiles of FX and NFX was developed. Simulation was performed with the model to generate FX and NFX concentration-time profiles in milk of 1000 mothers. This milk concentration-based pop PK model was compared with the previously validated plasma/milk concentration-based pop PK model of FX.
resultsMilk FX and NFX concentration-time profiles were described reasonably well by a one compartment model with a FX-to-NFX conversion coefficient. Median values of the simulated relative infant dose on a weight basis (sRID: weight-adjusted daily doses of FX and NFX through breastmilk to the infant, expressed as a fraction of therapeutic FX daily dose per body weight) were 0.028 for FX and 0.029 for NFX. The FX sRID estimates were consistent with those of the plasma/milk-based pop PK model.
conclusionsA predictive pop PK model based on only milk concentrations can be developed for simultaneous estimation of milk concentration-time profiles of a parent (FX) and an active metabolite (NFX).
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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.