Proton-Pump Inhibitor (PPI) Template for Pediatric Written Requests

6/24/02


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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)

Author: CDER USER