039 Simcyp Focused Workshop: Cardiac Safety M&S - November 16-18, 2021

Content
11 modules

Instructor
Kelly Turton

Released
13 May 2021

Price
£1,000.00

Description

Population‐based Mechanistic Assessment of Drugs Pro arrhythmic Potency Using In‐vitro and In‐vivo Extrapolation Approach.

The aim of the workshop is to present how mechanistic M&S can be used for the assessment of a drug’s pro-arrhythmic potency within target populations. Cardiac Safety Simulator can be used in the early stage of the drug development as a screening tool even in situations where no in-vitro data are available, or later at the clinical level to assess drug-drug or drug-physiology interactions.

The case studies will cover various elements of cardiac safety assessment including in vitro ion channels inhibition, clinical surrogates of cardiac safety and role of population variability all within the framework of simulated clinical trials. Participants will learn how to choose the most suitable models and also investigate the impact of various relevant assumptions on model performance.

Objectives

Key aspects covered in this course:

- Quick overview of models within the Simcyp CSS

- What are the most appropriate in vitro data for the cardiac safety testing and their simulation

- Application of population models for the drug-physiology interaction assessment

Certificate

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

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.
CSS Workshop Agenda & Pre Reading List
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3.
Simcyp Simulator Download instructions (Amazon Workspaces download)
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4.
A beginners Introduction to the Simcyp Simulator
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5.
Lecture Slide Decks for Download (and Files to be loaded)
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6.
Hands-on Assignments
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7.
Presentation and Office Hour Recording Links
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8.

CSS: Session 1 WebEx (UK Time Zone)

9.

CSS: Session 2 WebEx (UK Time Zone)

10.

CSS: Session 3 WebEx (UK Time Zone)

11.
Survey, please complete for Certificate
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