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Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps.

Authors :
Coppola, Paola
Berglund, Eva Gil
Rowland Yeo, Karen
Source :
CPT: Pharmacometrics & Systems Pharmacology. Nov2024, Vol. 13 Issue 11, p1830-1834. 5p.
Publication Year :
2024

Abstract

The article discusses the challenges of using medicines during pregnancy due to limited clinical data and the need for a clinical pharmacology extrapolation framework to support pregnancy drug development strategies. It highlights the regulatory landscape, the impact of pregnancy-related physiological changes on drug exposure, and the importance of including pregnant women in clinical trials. The article emphasizes the need for an extrapolation approach to generate data in pregnancy, focusing on mother and fetal safety management, study design, and labeling updates. Additionally, it suggests using model-informed drug development (MIDD) approaches, such as physiologically-based pharmacokinetic (PBPK) modeling, to predict drug exposure and inform dosing decisions during pregnancy. [Extracted from the article]

Details

Language :
English
ISSN :
21638306
Volume :
13
Issue :
11
Database :
Academic Search Index
Journal :
CPT: Pharmacometrics & Systems Pharmacology
Publication Type :
Academic Journal
Accession number :
181038604
Full Text :
https://doi.org/10.1002/psp4.13242