Clinical Study Options for locally acting nasal suspension products

7/20/01


Click here to start


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:

Author: Robert Meyer