043 Simcyp Focused Workshop: Best Practice in PBPK Model Building - February 21-25, 2022

Content
14 modules

Instructor
Kelly Turton

Released
03 Nov 2021

Price
£1,100.00

Description

It is assumed that the participants are familiar with the
fundamentals of PBPK modeling and have hands-on experience.

The main aim of this focused workshop is to demonstrate the application of best practices in
developing PBPK models, and to indicate how to qualify and refine model performance. Various
case studies, including some real-life examples, will be presented.
The case studies will cover various elements of model development including DDIs, special
populations, transporters, and different formulations. Optimal in vitro and clinical data sets will
be discussed. Participants will learn how to choose the most suitable models and also investigate
the impact of various relevant assumptions on model performance. Requirements for regulatory
submissions will also be discussed.

It is assumed that the participants are familiar with the
fundamentals of PBPK modeling and have hands-on experience.

 

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

Key aspects covered in this course:
• Hands-on experience using real-world case studies that have informed drug labels
• Quick overview of models within the Simcyp Simulator
• Model selection and how to pick the most suitable models
• What are the most appropriate in vitro data
• Leveraging clinical data to verify and refine PBPK model performance
• Application of special population models
• Application of sensitivity analysis in assessing the impact of uncertain parameters

Certificate

By completing/passing this course, you will attain the certificate Certificate of Completion - BP

1.
Pre Course Questionnaire - Your experience, expectations and area of interest, an optional survey to take prior to the course.
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2.
Best Practice Agenda, February 21-25, 2022
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3.
Pre Workshop Reading List, A selection of publications related to the Simcyp Simulator and model-informed drug development.
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4.
Simcyp Simulator Download instructions (Amazon Workspaces download)
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5.
A beginners Introduction to the Simcyp Simulator
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6.
Best Practice Slide Decks and Files for Loading
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7.
Hands-on Materials
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8.
Best Practice Presentation Recordings
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9.

Best Practice : Session 1 WebEx (UK Time Zone)

10.

Best Practice : Session 2 WebEx (UK Time Zone)

11.

Best Practice : Session 3 WebEx (UK Time Zone)

12.

Best Practice : Session 4 WebEx (UK Time Zone)

13.

Best Practice : Final office hour and conclusion WebEx (UK Time Zone)

14.
Survey, please complete for Certificate of completion
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