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Pharmacometric and Clinical Trial Design Core

The PCTDC supports clinical trial design, analysis, and precision therapeutics in maternal and pediatric populations through pharmacokinetic/pharmacodynamic modeling

Mother and Baby

About the PCTDC

The Pharmacometrics and Clinical Trial Design Core supports research projects that work to enhance our understanding of drug distribution and response in maternal and pediatric populations. 

Pharmacometrics and Clinical Design Faculty

Ongoing Projects

Gabapentin Pharmacokinetics in Postpartum Lactation

A clinical trial conducted by Drs. David Haas and Sara Quinney at Indiana University School of Medicine evaluated PK of gabapentin administered as part of a standard of care ERAS protocol.  Through population PK modeling, we estimated that the Relative Infant Dose (RID) through breast milk is <0.15% of maternal dose, indicating minimal exposure to breastfed neonates (<0.05 mg/kg/d). 

 

We are currently developing a PBPK model to further explore the disposition of gabapentin in pregnant, postpartum lactating, and neonatal populations.

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