Subcommittee Report: Orally Inhaled and Nasal Drug Products (OINDP)

12/20/00


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Table of Contents

Subcommittee Report: Orally Inhaled and Nasal Drug Products (OINDP)

Draft OINDP Guidance

Main BA/BE Guidance Issues

In Vitro BA/BE Questions To the OINDP Subcommittee (26 April 2000 Meeting)

Profile Analysis

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Profile Analysis

Profile Analysis

In Vitro Tests for DPIs: Comparability

In Vitro Tests for DPIs: Comparability

In Vitro Tests for DPIs: Comparability

In Vivo BA/BE Questions To the OINDP Subcommittee (26 April 2000 Meeting)

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Nasal Corticosteroid Dose-Response (e.g., Mometasone Furoate Nasal Spray)

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Clinical Studies for Local Delivery of Orally Inhaled Corticosteroids (ICS)

Clinical Studies for Local Delivery of ICS

Clinical Studies for Local Delivery of ICS

PK or PD Studies for Systemic Exposure of Locally Acting Drugs

PK or PD Studies for Systemic Exposure of Locally Acting Drugs

Acknowledgments

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PPT Slide

Author: CDER USER