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Draft Guidance Coverage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
|