Table of Contents
Lessons Learned: Successful Pediatric Drug Development
Successful Drug Development Programs in Pediatrics - Examples
Pediatric Drug Development Scenarios
Data FDA and Sponsors Consider When Determining Whether and When to Initiate Pediatric Studies
Whether to initiate pediatric studies:
Pre-clinical considerations for initiating pediatric trials - case study
Pre-clinical data factor into risk/benefit assessment: the Quinolones
Extrapolation of efficacy from adult trials to pediatric patients
December 13, 1994 regulations
Case study: evidentiary standards for extrapolation
Efficacy Measurements in Pediatrics Studies
When should alternative outcome measures be explored?
Aspects of Trial Conduct Unique to Pediatric Clinical Trials
Elements of a pediatric clinical trial
Summary
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