ORALLY INHALED AND NASAL DRUG PRODUCTS FOR LOCAL ACTION Current FDA BA/BE Background and Issues

5/8/00


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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

Author: Wally Adams