Statistical Evaluation of In Vitro Bioequivalence for Nasal Aerosols and Nasal Sprays for Local Action：Droplet size Distribution
Date Issued
2008
Date
2008
Author(s)
Yue, Chung-hsien
Abstract
In order to evaluate bioequivalence between the generic and innovator investigate the equivalence in characteristics between the generic and innovator nasal aerosols. Because the nasal aerosols only act locally and its active ingredient does not absorb into the body system, therefore in vivo bioequivalence studies are replaced by the in vitro bioequivalence studies using machinery experiment to avoid variability caused the factors much that volume of breath. The quality of nasal aerosols and sprays can be characterized by spray patterns, droplet size distribution and plume geometry. The 2003 US FDA draft guidance proposed the application of population bioequivalence to evaluate the in vitro bioequivalence between the generic and innovator nasal aerosols and sprays. Such analysis is referred to as the nonprofile analysis. We applied the statistical methods of in vitro bioequivalence in the US FDA guidance to a dataset of droplet size distribution. We also compare and discuss the results obtained under the 2-stage nested random-effects model and the model suggested in the 2003 US FDA draft guidance.
Subjects
Nasal Aerosols, Droplet Size Distribution, Spray Pattern, Plume Geometry, Linearized Criterian
Type
thesis
File(s)![Thumbnail Image]()
Loading...
Name
ntu-97-R95621208-1.pdf
Size
23.32 KB
Format
Adobe PDF
Checksum
(MD5):510b452d51dfc45dc2bcaf2e8811fd65