PK and PD Studies for Systemic Exposure of Locally Acting Drugs Industry View

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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

Author: lester i harrison