Modeling and Simulation in Pediatric Drug Development: Applications of “Top-Down” and “Bottom-Up" Approaches to Optimize Trial Design and Support Dosing Rationale

Tuesday, October 9 2012
11:00 am – 12:00 pm

Location: Online Event

Presenters:
Trevor Johnson, PhD, Principal Scientist
Simcyp Limited, part of Certara™

JF Marier, PhD, FCP, Vice President and Lead Scientist
Pharsight Consulting Services, part of Certara™

Webinar Description:
The challenges and complexities of conducting clinical studies in pediatric populations are well recognized. To meet some of these challenges, industry has adopted specific methods for optimizing pharmacokinetic (PK) and pharmacodynamic (PD) assessment in pediatrics, while minimizing the number of blood samples collected and the sample size of subjects enrolled in a clinical study. Traditional “top-down” scaling of data collected in adults has been used to inform pediatric trial designs and provide additional confidence in dosing decisions. As the advantages of modeling and simulation have become increasingly well documented, regulatory authorities have challenged industry to more rigorously apply these tools to double the success rate of pediatric trials.

Complimenting these approaches, “bottom-up” physiologically based pharmacokinetic (PBPK) models have been used in pediatrics to integrate information from human physiology and detailed biological factors and interactions to describe drug absorption and disposition processes. Over the past decade there have been notable advances in the sophistication and accuracy of physiologic data and tools for performing PBPK analysis and simulations, as evidenced by increased PBPK submissions to FDA and the use of PBPK models to predict drug exposure in pediatric patients.

This webinar will present general principles of modeling and simulation to optimize pediatric trial design and support dosing rationale to ensure adequate safety and efficacy of treatments intended for pediatric use. Both “top-down” and “bottom-up” approaches will be discussed as part of a modeling framework to better understand and predict complex drug and system dynamics. The session will include case examples of these synergistic approaches in a shared clinical indication.

Time will be reserved for a Q&A session.

Who Should Attend:

-- Clinical pharmacologists
-- Regulatory scientists
-- Clinicians
-- Team members responsible for pediatric strategy & trial design
-- Statisticians
-- Translational researchers

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