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Safety Assessment in Pediatrics
Safety Historical perspective
Assumption:
“Off-label is bad”
Consequences
Concerns
Toxicity
Years of “experimentation” have resulted in enough experience to allow for the safe and effective use for drugs such as the penicillins and aminoglycosides
Why not?
Is licensed “good”?
Safety assessment during drug development - premarketing
Preclinical considerations re: juvenile animal studies
Juvenile animal studies
Clinical trial information
Types of studies requested
Safety studies
Pediatric specific reporting
Postmarketing safety information
FDA Adverse Event Reporting System (AERS) Database
Report Processing in AERS
PPT Slide
Features of a Spontaneous Reporting System: Source of Reports
Direct Reports: 10-15% of Reporting #11; MedWatch Program (1993)
Features of a Spontaneous Reporting System: Signal Generation
Signal Evaluation: Epidemiologic Analysis of Selected Issues
Percentage of AERs cases by age 1997-1998
Download presentation source
Last update: July 11, 2005
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