Table of Contents
Clinical Study Options for locally acting nasal suspension products
Introduction
What are the options?
Types of Studies:
Types of Studies:
Types of Studies:
Types of Studies:
What is the Question for the Clinical study in the BE setting?
If Intent is to Confirm Other Data:
If Intent is to Establish BE:
FDA experience:
FDA experience (continued):
If “Equivalence” In Vitro and Systemic Exposure are shown:
If “Equivalence” In Vitro and Systemic Exposure are shown:
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Author: Robert Meyer
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