053 Intensive 10-day Workshop on Model-informed Drug Development - May 9-20, 2022

Content
18 modules

Instructor
Kelly Turton

Released
16 Nov 2021

Price
£3000 - 3800

Description

Incorporating population variability into mechanistic prediction of PK and modeling PK/PD
The model-informed approach to various aspects of drug development is rapidly being adopted by the leading pharmaceutical
companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drugs and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions, and eventually implement precision medicine.

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

Delegates will learn how to simulate and predict:

• Metabolic drug clearance (CL)
• Metabolic drug-drug interactions (DDIs)
• Gut first-pass metabolism
• Oral drug absorption incorporating food effects and the impact of dosage form
• Effect of transporters and enterohepatic recirculation on kinetics and DDIs
• Drug distribution to different organs
• Population variability in drug concentration-time profiles
• Variation in kinetics in specific populations (pediatrics, ethnic groups, various disease populations)
• Modeling of therapeutic proteins
• Pharmacodynamic effects of different compounds
• Time-course of drug in plasma that fits observed clinical data (achieved by combining fitting techniques with IVIVE, PBPK and drug-specific in vitro data)

Certificate

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

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.
Agenda, Amazon Workspace user guide & Pre Reading List - Intensive 10-day Workshop on Model-informed Drug Development
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3.
A beginners Introduction to the Simcyp Simulator
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4.
Lecture Slide Decks for Download (and files to be loaded)
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5.
Hands-on Assignments
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6.
Presentation and Office Hour Recordings Links
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7.
References and Papers
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8.

Full WKS: Session 1 - WebEx (UK Time Zone)

9.

Full WKS: Office Hour and Session 2 - WebEx (UK Time Zone)

10.

Full WKS: Office Hour and Session 3 - WebEx (UK Time Zone)

11.

Full WKS: Office Hour and Session 4 - WebEx (UK Time Zone)

12.

Full WKS: Office Hour and Session 5 - WebEx (UK Time Zone)

13.

Full WKS: Office Hour and Session 6 - WebEx (UK Time Zone)

14.

Full WKS: Office Hour and Session 7 - WebEx (UK Time Zone)

15.

Full WKS: Office Hour and Session 8 - WebEx (UK Time Zone)

16.

Full WKS: Office Hour and Session 9 - WebEx (UK Time Zone)

17.

Full WKS: Office Hour and Session 10 - WebEx (UK Time Zone)

18.
Survey, please complete for Certificate of completion
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