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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 here reviewed recent progress, challenges and potential solutions for the application of PBPK, PopPK, and exposure-response analyses in clinical drug development for pregnancy.
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