Physiologically based pharmacokinetic modelling in pregnancy: Model reproducibility and external validation.
Larissa L SilvaRebecca M SilvolaDavid M HaasSara K QuinneyPublished in: British journal of clinical pharmacology (2021)
While high interstudy variability was observed in the newly available clinical data, the PBPK model sufficiently predicted changes in betamethasone exposure across gestation. Model reproducibility and reassessment with external data are important for the advancement of the discipline. PBPK modelling publications should contain sufficient detail and clarity to enable reproducibility.