Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

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Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

Bioequivalence is assumed when the 90% confidence interval ranges between 80 - 120% for the target parameters (for normally distributed data).

Three Clinical Models

Model 1 continuedDAY(S) IN THE PARK STUDY

Model 2 continuedENVIRONMENTAL UNIT

Model 3 continued TRADITIONAL CLINICAL STUDY

Improvements toTraditional Study Model

General Problems withIn-Vivo Bioequivalence Studies

General Problems withIn-Vivo Bioequivalence Studies continued

Author: LLOYD BAROODY