Journal
FRONTIERS IN PEDIATRICS
Volume 9, Issue -, Pages -Publisher
FRONTIERS MEDIA SA
DOI: 10.3389/fped.2021.687978
Keywords
physiologically-based pharmacokinetics modelling; pharmacokinetics; pregnancy PBPK; foetal PBPK; breastfeeding PBPK; PBPK qualification; regulatory submissions
Categories
Funding
- Bill & Melinda Gates Foundation, Seattle, Washington, USA
Ask authors/readers for more resources
PBPK modelling is widely used in medicine development and regulatory submissions, especially in studying drug pharmacokinetics during pregnancy. Physiological changes during pregnancy may have potential impact on drug pharmacokinetics, so qualified models are needed to support high-risk decisions.
Physiologically based pharmacokinetics (PBPK) modelling is widely used in medicine development and regulatory submissions. The lack of clinical pharmacokinetic data in pregnancy is widely acknowledged; therefore, one area of current interest is in the use of PBPK modelling to describe the potential impact of anatomical and physiological changes during pregnancy on the medicine's pharmacokinetics. PBPK modelling could possibly represent a predictive tool to support the medicine benefit-risk decision and inform dose adjustment in this population and also to investigate medicine levels in the foetus to support the risk assessment to the foetus. In the context of regulatory application, there are, however, a number of considerations around model evaluation, and this should be tailored to the model purpose, in order to inform the confidence in the model for the intended application. A number of gestational age-related physiological changes are expected to alter the pharmacokinetics of medicines during pregnancy, and there are uncertainties on some parameters; therefore, well-qualified models are needed to improve assurance in the model prediction before this approach can be used to inform with confidence high-impact decisions as part of regulatory submissions.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available