Description
Certara UK Limited is running a Simcyp hands-on workshop discussing the changes to pharmacokinetics during pregnancy and the prediction of pharmacokinetics (including in the milk) during lactation. Population based Physiologically Based Pharmacokinetic (PBPK) approach will be utilized to describe the pharmacokinetics during pregnancy and lactation and to determine population variability.
The major topics covered are:
Maternal and fetal gestational age-dependent physiological changes
Prediction of maternal and fetal drug pharmacokinetics
Ways of incorporating ex vivo experimental data on transplacental kinetics within the PBPK model
Handling gestational age-varying covariates during simulation
Prediction of PK in breastfeeding mothers and milk exposure using lactation models
Prediction of infant dose for breastfed infant
This course will be run using the Amazon Workspaces in Cloud; please ensure you have access to a computer.
Live Online Courses
There are no refunds for Live Online courses. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
Objectives
To understand the requirements in developing for maternal/fetal and lactation PBPK models using hands-on examples.
To get familiar with different pregnancy/lactation PBPK models assumptions within the Simulator, interpretation of the results to make recommendations using clinical examples.
To be able to integrate experimental results within the pregnancy and lactation PBPK framework.
Upon completion, participants should be able to recognize opportunities and challenges in applying quantitative modelling and simulation tools in the field of perinatal pharmacology.
Upon completion, participants should be able to utilise the advantages of PBPK models in providing information during drug development and in clinical settings.
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