FDA Nasal BA/BE Guidance Overview

4/24/00


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Table of Contents

FDA Nasal BA/BE Guidance Overview

Draft Guidance Coverage

Approaches to Measure BA and Establish BE

Locally Acting Drug Products (LADP)

BA and BE Concepts for LADP

General BA and BE Approach

In Vitro BA and BE Data

In Vitro BA and BE Data: Specific Tests

In Vivo BA and BE Data

Clinical Study for Local Delivery

Systemic Exposure or Systemic Absorption

Importance of In Vitro Data for Establishing BE

Number and Type of Batches (Draft Recommendation)

Batches for Clinical Study for Local Delivery (Draft Recommendation)

Batches for Systemic Exposure or Systemic Absorption Study (Draft Recommendation)

Draft Nasal BA/BE Guidance: Continuing Work Includes -

PPT Slide

Oral Inhalation BA/BE Guidance for LADP: Draft Table of Contents

Acknowledgments

Author: Wally Adams