Description
November 11-15, 2024 | ONLINE
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
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