Table of Contents
Timing of Pediatric Studies in Relation to Adult Studies
Importance of Pediatric Clinical Trials
It is important that drug products be studied in the range of patients for which the drug will be administered
“Because Lives Depend On It”
1998 Pediatric Rule
Phases of Drug Development
Draft Guidelines of the American Academy of Pediatrics (AAP)
Draft Pediatric Guidelines of the International Conference on Harmonization (ICH)
Draft Pediatric Guidelines of the International Conference on Harmonization (ICH)
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Potential Need for Pediatric Formulations - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Severity of the Condition - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Availability of Alternative Therapies - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Prevalence of the Condition in Children - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Unknown versus Known - ICH
Factors to Consider when Timing Pediatric Clinical Trials - ICH
Age Range of Children to be Treated
The Regulatory Process - ICH
The Regulatory Process - ICH
Other Significant Guidance Documents
Summary Statements American Academy of Pediatrics (Draft), Australia, Canada, European Union
Operative Principles
Operative Principles
Discussion Points
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