Toward Greater Insights on Applications of Modeling and Simulation in Pregnancy

Author(s): Ling Song, Cheng Cui, Ying Zhou, Zhongqi Dong, Zhiheng Yu, Yifan Xu, Tianyan Zhou, Khaled Abduljalil, Hongcan Han, Li Li, Jinbo Yang, Yangyu Zhao*, Haiyan Li, Dongyang Liu*

Journal Name: Current Drug Metabolism

Volume 21 , Issue 9 , 2020


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Abstract:

Pregnant women are often excluded from routine clinical trials. Consequently, appropriate dosing regimens for majority of drugs are unknown in this population, which may lead to unexpected safety issue or insufficient efficacy in this un-studied population. Establishing evidence through the conduct of clinical studies in pregnancy is still a challenge. In recent decades, physiologically-based pharmacokinetic (PBPK) modeling has proven to be useful to support dose selection under various clinical scenarios, such as renal and/or liver impairment, drug-drug interactions, and extrapolation from adult to children. By integrating gestational-dependent physiological characteristics and drug-specific information, PBPK models can be used to predict PK during pregnancy. Population pharmacokinetic (PopPK) modeling approach also could complement pregnancy clinical studies by its ability to analyze sparse sampling data. In the past five years, PBPK and PopPK approaches for pregnancy have made significant progress. We reviewed recent progress, challenges and potential solutions for the application of PBPK, PopPK, and exposure-response analysis in clinical drug development for pregnancy.

Keywords: Pregnancy, modeling-and-simulation, clinical trial, physiologically-based-pharmacokinetic, population-pharmacokinetic, exposure- response analysis.

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Article Details

VOLUME: 21
ISSUE: 9
Year: 2020
Published on: 14 December, 2020
Page: [722 - 741]
Pages: 20
DOI: 10.2174/1389200221666200907143941
Price: $65

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