Table of Contents
PK and PD Studies for Systemic Exposure of Locally Acting Drugs Industry View
Value of OINDP PK
OINDP PK Concerns
OINDP PK Concern: Low Doses
OINDP PK Concern: Assay LLOQ
OINDP PK Concern: Variability
Nasal Formoterol Variability N = 27
Nasal Triamcinolone Acetonide Variability N = 12
Nasal Budesonide Variability N = 16
Oral Inhalation Fluticasone Variability N = 12
Reducing Variability
BE Limitations of OINDP PK
Nasal Fluticasone PK & Efficacy N = 280
Oral Inhaled Fluticasone PK & Efficacy N = 261
Value of OINDP PK: Conclusions
BDP MDI Examples Systemic Absorption Studies
BDP Comparative Absorption Studies MDI A vs. MDI B
Oral Inhaled BDP PK Study 1
Oral Inhaled BDP PK Study 2
BDP MDI Examples Systemic Absorption Studies
BDP Comparative Absorption Studies MDI C vs. MDI D
Oral Inhaled BDP PK Study 3
Oral Inhaled BDP PK Study 4
PK Options: Charcoal Block
BE Limitations of Charcoal Block
PK Options: Urinary Excretion
Nasal Ipratropium Bromide N = 22
BE Limitations of Urinary Excretion
PK Options: PD Measurement
BE Limitations of PD
PK Options: PK-PD
BE Limitations of PK-PD
SUMMARY
FDA Question: Are There Situations Where In Vitro Data + PK + PD Can Be Relied on to Assure Local Efficacy
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