Addressing drug safety of maternal therapy during breastfeeding using physiologically‐based pharmacokinetic modeling
Author:
Affiliation:
1. Simcyp Division Certara UK Limited Sheffield UK
Publisher
Wiley
Subject
Pharmacology (medical),Modeling and Simulation
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12802
Reference10 articles.
1. Prediction of drug concentrations in milk during breastfeeding, integrating predictive algorithms within a physiologically‐based pharmacokinetic model
2. Increasing application of pediatric physiologically based pharmacokinetic models across academic and industry organizations
3. USFood and Drug Administration (FDA).Clinical lactation studies: considerations for study design. Guidance for industry. Draft guidance.https://www.fda.gov/media/124749/download(2019).
4. Clinical lactation studies and the role of pharmacokinetic modeling and simulation in predicting drug exposures in breastfed infants
5. Models and methods for predicting drug transfer into human milk
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1. EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding;CPT: Pharmacometrics & Systems Pharmacology;2024-08-13
2. 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;2023-12-12
3. Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy;Pharmaceutics;2023-10-13
4. Informing a Comprehensive Risk Assessment of Infant Drug Exposure From Human Milk: Application of a Physiologically Based Pharmacokinetic Lactation Model for Sotalol;The Journal of Clinical Pharmacology;2023-06
5. Quantitative approaches to drug safety: The 2022 PSP special issue;CPT: Pharmacometrics & Systems Pharmacology;2022-05
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