PHARMACOKINETIC STUDIES FOR ORAL INHALATION AEROSOLS AND NASAL SPRAYS - CURRENT FDA PRACTICES

5/8/00


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Table of Contents

PHARMACOKINETIC STUDIES FOR ORAL INHALATION AEROSOLS AND NASAL SPRAYS - CURRENT FDA PRACTICES

Outline

Pharmacokinetics/Biopharmaceutics Clinical Pharmacology (General requirements for NMEs as inhalation/nasal products)

Pharmacokinetics/Biopharmaceutics Clinical Pharmacology (General requirements for NMEs) (continued)

PPT Slide

Approaches to establish bioavailability/bioequivalence

Fate of inhaled drug products

Why not BA/BE based on PK alone

PK studies for locally acting, orally inhaled drug products

Inhalation PK with charcoal block

Lung deposition - Gamma scintigraphy

New oral inhalation products

Role of systemic PK and PD studies for locally acting, orally inhaled drug products

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Summary

Summary (continued)

Author: CDER USER