046 Simcyp Focused Workshop: Paediatrics - March 7-11, 2022

Content
15 modules

Instructor
Kelly Turton

Released
03 Nov 2021

Price
£1,100.00

Description

Predicting age related changes to pharmacokinetics (PK) and drug-drug interactions including
associated variability—linking this information to drug response in the pediatric population.
Participants will learn how PK behavior can be modeled in preterm and term neonates, infants,
and children and how it can be linked to predict the drug response (PD) within the PBPK platform.
Hands-on exercises explore how this valuable information is relevant to early and informed
decisions to assist in the improved design of pediatric clinical studies.

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:
• The impact of developmental physiology and ontogeny of drug elimination systems
• How system parameters “covariates” are inter-correlated within the Pediatric Simcyp Simulator
• In vitro-in vivo extrapolation (IVIVE) and how it applies to neonates, infants, and children

How changing ontogeny influences the level of drug-drug interactions in pediatrics
• Development and utilization of a pediatric full PBPK model
• How the PBPK model can be linked to PD
• Handling unknown values for pediatric PBPK/PD model parameters
• Pediatric oral drug absorption
• Prediction of therapeutic protein in children
• Specialized study design considerations (eg, formulation, diet) and how PBPK models can be used to help optimize pediatric PK study design
• The role of modeling and simulation in pediatric drug development and the current views of regulators

Certificate

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

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.
Pediatrics Agenda, March 7-11, 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.
Slide Decks and Files for Loading - Pediatrics
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7.
Hands-on Materials
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8.
Presentation Recordings - Pediatrics
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9.

Pediatrics: Session 1 WebEx (UK Time Zone)

10.

Pediatrics: Session 2 WebEx (UK Time Zone)

11.

Pediatrics: Session 3 WebEx (UK Time Zone)

12.

Pediatrics: Session 4 WebEx (UK Time Zone)

13.

Pediatrics: Session 5 WebEx (UK Time Zone)

14.

Pediatrics: Office Hour and Conclusion WebEx (UK Time Zone)

15.
Survey, please complete for Certificate of completion
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