054 Simcyp Focused Workshop: PK during Pregnancy and Lactation: June 13-15, 2022

13 modules

Kelly Turton

12 Jan 2022



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.


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. 


By completing/passing this course, you will attain the certificate Certificate of completion - Pregnancy and Lactation

Pre Course Questionnaire - Your experience, expectations and area of interest, an optional survey to take prior to the course.
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Agenda, Physiologically Based Pharmacokinetic Modelling during Pregnancy and Lactation - June 13-15, 2022
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Pre Workshop Reading List, A selection of publications related to the Simcyp Simulator and model-informed drug development.
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Simcyp Simulator Download instructions (Amazon Workspaces download)
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A beginners Introduction to the Simcyp Simulator
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Slide Decks and Files for Loading
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Hands-on Materials
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Presentation Recordings - Pregnancy & Lactation
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Pregnancy and Lactation: Session 1 WebEx (UK Time Zone)


Pregnancy and Lactation: Session 2 WebEx (UK Time Zone)


Pregnancy and Lactation: Session 3 WebEx (UK Time Zone)


Pregnancy and Lactation: Final Office Hour and Conclusion (UK Time Zone)

Survey, please complete for Certificate of completion
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