Lessons Learned: Successful Pediatric Drug Development

5/3/99


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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

Author: CBER