The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues

7/20/01


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Table of Contents

The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues

NASAL AEROSOLS (MDIs) AND NASAL SPRAYS*

OUTLINE

History (a)

History (b)

History (c)

METHODS FOR DOCUMENTATION OF BE*

APPLICATION OF BE STUDIES

BE RECOMMENDATIONS Formulation Equivalence

BE RECOMMENDATIONS The Device

BE RECOMMENDATIONS Comparable In Vitro Performance (a)

BE RECOMMENDATIONS: Comparable In Vitro Performance (b)

LOCAL DELIVERY Clinical Endpoint in SAR Patients

SYSTEMIC EXPOSURE STUDY (PK)

SYSTEMIC ABSORPTION STUDY (PD)

BE RECOMMENDATIONS (OVERVIEW)

THE LOCAL DELIVERY ISSUES*

DOSE-RESPONSE

PROPOSAL FOR BE STUDY NASAL SUSPENSION AEROSOLS AND SPRAYS

ACKNOWLEDGMENTS

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THE END

PROPOSED BE CRITERION FOR NONPROFILE DATA

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DATA ANALYSIS

Author: Wally Adams