Clinical Studies for Local Delivery of Nasal Aerosols and Sprays

5/8/00


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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 continued DAY(S) IN THE PARK STUDY

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Model 2 continued ENVIRONMENTAL UNIT

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Model 3 continued TRADITIONAL CLINICAL STUDY

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Improvements to Traditional Study Model

General Problems with In-Vivo Bioequivalence Studies

General Problems with In-Vivo Bioequivalence Studies continued

Author: LLOYD BAROODY