Physiologically based pharmacokinetic modelling in pregnancy: Model reproducibility and external validation.

ABSTRACT:

Aims

Physiologically based pharmacokinetic (PBPK) models have been previously developed for betamethasone and buprenorphine for pregnant women. The goal of this work was to replicate and reassess these models using data from recently completed studies.

Methods

Betamethasone and buprenorphine PBPK models were developed in Simcyp V19 based on prior publications using V17 and V15. Ability to replicate models was verified by comparing predictions in V19 to those previously published. Once replication was verified, models were reassessed by comparing predictions to observed data from additional studies in pregnant women. Model performance was based upon visual inspection of concentration vs. time profiles, and comparison of pharmacokinetic parameters. Models were deemed reproduci

SUBMITTER: Silva LL 

PROVIDER: S-EPMC10293961 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature