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PBPK in Preterm and Term Neonates: A Review
Robin Michelet1,2, Jan Van Bocxlaer1,2, An Vermeulen1,2
1Laboratory of Medical Biochemistry and Clinical Analysis, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Belgium.
Current Pharmaceutical Design
|October 10, 2017
Summary
Physiologically based pharmacokinetic modeling (PBPK) aids neonatal drug research by addressing dosing challenges. The "middle-out" approach, combining bottom-up modeling with clinical data, shows promise for optimizing neonatal medication.
Area of Science:
- Pharmacokinetics
- Neonatal Pharmacology
- Computational Biology
Background:
- Neonatal populations often lack appropriate dosing regimens, leading to significant off-label drug use.
- Clinical research in neonates is challenging, highlighting the need for advanced research tools.
- Physiologically based pharmacokinetic (PBPK) modeling offers a promising approach for neonatal drug research.
Purpose of the Study:
- To investigate the application and feasibility of PBPK modeling in preterm and term neonates.
- To compare different PBPK approaches (top-down, bottom-up, middle-out) for neonatal drug research.
- To identify challenges and propose solutions for implementing PBPK in this vulnerable population.
Main Methods:
- Review and comparison of top-down, bottom-up, and middle-out PBPK modeling strategies.
- Analysis of existing literature on PBPK applications in neonates.
- Identification of challenges and potential solutions for PBPK implementation in neonatal populations.
Main Results:
- PBPK modeling in neonates has gained attention but knowledge gaps persist.
- The study compared various PBPK approaches, noting challenges specific to the neonatal population.
- A preference for the "middle-out" approach, integrating bottom-up PBPK with clinical data, was observed.
Conclusions:
- PBPK modeling is a valuable tool for neonatal drug research and development.
- The "middle-out" approach shows significant potential for optimizing neonatal dosing.
- Further application of PBPK can guide First-in-Human/Neonate trials and personalize neonatal medication.
