Table of Contents
Proton-Pump Inhibitor (PPI) Template for Pediatric Written Requests
Outline
Introduction
Rationale
Extrapolation of Efficacy Data
< 1 year of age
ɭ year of age
Requested Studies by Age Group
12 Years to 16 Years of Age (Study 6)
1 Year to 11 Years of Age (Study 5)
1 Month to 11 Months of Age (Study 3)
1 Month to 11 Months of Age (Study 4)
1 Month to 11 Months of Age (Study 4) (cont’d)
1 Month to 11 Months of Age (Study 4) (cont’d)
Neonates and Preterm Infants with a Corrected Age វ Weeks (Study 1)
Neonates and Preterm Infants with a Corrected Age វ Weeks (Study 1) (cont’d)
Neonates and Preterm Infants with a Corrected Age វ Weeks (Study 2)
Neonates and Preterm Infants with a Corrected Age វ Weeks (Study 2) (cont’d)
Neonates and Preterm Infants with a Corrected Age វ Weeks (Study 2) (cont’d)
Neonates and Preterm Infants with a Corrected Age វ Weeks (Study 2) (cont’d)
Overall Summary
Overall Summary (cont’d)
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