|
Activity Number:
|
140
- The Challenges and Advantages of Utilizing Bayesian Statistical Methodology in Extrapolation of Adult Use Data to Pediatric Study Designs and Evaluation
|
|
Type:
|
Invited
|
|
Date/Time:
|
Monday, July 31, 2017 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #322055
|
View Presentation
|
|
Title:
|
Bayesian Statistical Methodologies for Evaluating Similarity in Exposure-Response Relationship Between Adults and Pediatrics
|
|
Author(s):
|
Mathangi Gopalakrishnan*
|
|
Companies:
|
Center for Translational Medicine, University of Maryland, Baltimore
|
|
Keywords:
|
Exposure-response ;
PK/PD ;
Bayesian ;
Pediatric Extrapolation ;
Epilepsy
|
|
Abstract:
|
Clinical trials in pediatrics rely on the prior knowledge of efficacy and safety from adults. Showing similarity of a) disease progression b) treatment response c) drug exposure d) exposure-response (PK/PD) in adults and pediatrics would allow for full extrapolation of efficacy in pediatrics. However, quantitative methodologies for assessment of similarity in exposure-response are limited with most of the full extrapolation decisions made on clinical judgement and qualitative assessments. Recently, the FDA released a policy statement that extrapolation of efficacy from adults to pediatric patients (> 4 years of age) for adjunctive therapy of partial seizures is acceptable based on quantitative PK/PD assessments of several anti-epileptic drugs approved. Assessing the similarity of the PK/PD relationship by borrowing information from adults, for extrapolation in pediatrics, naturally fits into the Bayesian paradigm. This talk will discuss about Bayesian methodologies to assess similarity of exposure-response between adults and pediatrics. Different methods of prior elicitation from adult data and Bayesian hierarchical modeling will be discussed with a case study in epilepsy.
|
Authors who are presenting talks have a * after their name.
Back to the full JSM 2017 program
|
