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Optimization of Drugs Pharmacotherapy During Pregnancy Using Physiologically Based Pharmacokinetic Models - An Update

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Background: Clinical studies during pregnancy are rare due to ethical and practical limitations. Giving pregnant females the same dosing regimen used in adult males or nonpregnant females is inappropriate. Pregnancy physiologically-based pharmacokinetic modeling is a powerful tool that can be used to refine pharmacotherapy during pregnancy.

Objective: This work provides a review of the current status of application of physiologically based pharmacokinetic models in developing dosing regimens in pregnant women.

Methods: A structured search was done on Scholar Google, Science Direct and PubMed. The articles searched were those providing physiological, anatomical and biochemical data needed for pregnancy physiologically-based pharmacokinetic models or utilizing these models to evaluate the effect of pregnancy on drugs pharmacokinetics. Key words used for search include: PBPK and pregnancy, pharmacokinetic during pregnancy, ethics of pregnancy studies. The found articles were evaluated in terms of main pharmacokinetic features of the drug that were affected by pregnancy, the structure of the model, the software platform used and quality of predicted maternal and fetal exposure.

Results: Pregnancy physiologically-based pharmacokinetic models can be used to optimize effective and safe dosing regimens needed during pregnancy. Different model structures have been successfully used for this purpose using different modeling software.

Conclusion: More work is needed to fill the gaps in knowledge needed to more accurately and mechanistically simulate simultaneous exposure of the pregnant mother and her fetus/ embryo to drugs using pregnancy physiologicallybased pharmacokinetic modeling approach.
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Keywords: Pregnancy; ethics; model structure; physiologically-based pharmacokinetic; pregnancy clinical studies; software

Document Type: Review Article

Publication date: October 1, 2018

This article was made available online on July 18, 2018 as a Fast Track article with title: "Optimization of Drugs Pharmacotherapy During Pregnancy Using Physiologically Based Pharmacokinetic Models - An Update".

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  • Current Drug Metabolism aims to cover all the latest and outstanding developments in drug metabolism and disposition. The journal serves as an international forum for the publication of timely reviews in drug metabolism. Current Drug Metabolism is an essential journal for academic, clinical, government and pharmaceutical scientists who wish to be kept informed and up-to-date with the latest and most important developments. The journal covers the following areas:

    In vitro systems including CYP-450; enzyme induction and inhibition; drug-drug interactions and enzyme kinetics; pharmacokinetics, toxicokinetics, species scaling and extrapolations; P-glycoprotein and transport carriers; target organ toxicity and interindividual variability; drug metabolism and disposition studies; extrahepatic metabolism; phase I and phase II metabolism; recent developments for the identification of drug metabolites and adducts.
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