Table of Contents
ORALLY INHALED AND NASAL DRUG PRODUCTS FOR LOCAL ACTION Current FDA BA/BE Background and Issues
ORALLY INHALED AND NASAL DRUG PRODUCTS FOR LOCAL ACTION Current FDA BA/BE Background and Issues
Two Product Quality Guidances
Draft Guidances Coverage
Approaches to Measure BA and Establish BE
Locally Acting Drug Products (LADP)
BA and BE Concepts for LADP
Formulation and Container/Closure System
In Vitro BA and BE Data
In Vitro BA and BE Data: Specific Tests for MDIs and Nasal Sprays
In Vitro BE: Statistical Comparisons under Development
Proposed BE Criterion For CU
PPT Slide
In Vivo BA and BE Data
BE Studies for Nasal Sprays
BE Studies for Nasal Sprays
PD BE Studies for Inhalation Aerosols (Albuterol MDI)
PD-BE Studies for Inhalation Aerosols (Albuterol MDI)
BE Studies for Inhalation Aerosols
Data Analysis
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