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)
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Author: CDER USER
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