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
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