Timing of Pediatric Studies in Relation to Adult Studies

5/3/99


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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

Author: Steven Hirschfeld