Table of Contents
PHARMACOKINETIC TESTING FOR SYSTEMIC EXPOSURE OF ORALLY INHALED AND NASAL DRUGS
Outline
Why nasal and oral inhalation delivery
Approaches to establish bioavailability/bioequivalence
PPT Slide
Why not BA/BE based on PK alone
Fate of inhaled drug products
Inhalation PK with charcoal block
Lung deposition - Gamma scintigraphy
Nasal Guidance
Decision tree for in vivo product quality BA/BE studies for nasal products
Albuterol metered dose inhaler
Nasal Guidance - PK recommendations
Examples of locally acting nasal products
Examples of systemically acting nasal products
Study designs used in these examples
PK studies: Issues
PK studies: Feasibility
Examples of oral inhalation products
Study designs used in these examples
PK studies: Issues
PK studies: Feasibility
PPT Slide
Summary
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