050 Simcyp Focused Workshop: FIH - March 28 -April 1, 2022

Content
14 modules

Instructor
Kelly Turton

Released
03 Nov 2021

Price
£1,100.00

Description

In this focused workshop participants will use the dynamic models within the Simcyp Simulator to
prioritize compounds for progress to the next stage of development using information available in
early drug discovery. Participants will use information on clearance, absorption, tissue distribution
and DDI liability to inform compound selection. Finally, from the originally large database, only a few
compounds will be selected for FIH and the simulation results compared with available clinical data.
The case studies will cover various elements of model development including DDIs, special
populations to pre-clinical species, transporters, and different formulations. Optimal in vitro and
clinical data sets for PBPK model building 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. An appraisal of regulatory requirement for FIH studies and considerations for
regulatory acceptance of PBPK simulations will 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

During the workshop you will be shown how to use a number of tools including:

• SIVA toolkit

• Batch Processor

• Compound import

• Sensitivity analysis

• Parameter estimation

• Using R to run Simcyp

• Retrograde calculator

Certificate

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

1.
Pre Course Questionnaire - Your experience, expectations and area of interest, an optional survey to take prior to the course.
{{ vm.helper.t('courses.survey') }}
2.
FIH Agenda, March 28- April 1, 2022
{{ vm.helper.t('reports.module') }}
3.
Pre Workshop Reading List, A selection of publications related to the Simcyp Simulator and model-informed drug development.
{{ vm.helper.t('reports.module') }}
4.
Simcyp Simulator Download instructions (Amazon Workspaces download)
{{ vm.helper.t('reports.module') }}
5.
A beginners Introduction to the Simcyp Simulator
{{ vm.helper.t('reports.module') }}
6.
Slide Decks and Files for Loading - FIH
{{ vm.helper.t('reports.module') }}
7.
Hands-on Materials
{{ vm.helper.t('reports.module') }}
8.
Presentation Recordings - FIH
{{ vm.helper.t('reports.module') }}
9.

FIH: Session 1 WebEx (UK Time Zone)

10.

FIH: Session 2 WebEx (UK Time Zone)

11.

FIH: Session 3 WebEx (UK Time Zone)

12.

FIH: Session 4 WebEx (UK Time Zone)

13.

FIH: Session 5 and Conclusion of the course WebEx (UK Time Zone)

14.
Survey, please complete for Certificate of completion
{{ vm.helper.t('courses.survey') }}

Shopping Cart

Your cart is empty