Analytical Challenges of Spray Pattern Method Development for Purposes of In Vitro Bioequivalence Testing in the Case of a Nasal Spray Product.

08:00 EDT 8th April 2019 | BioPortfolio

Summary of "Analytical Challenges of Spray Pattern Method Development for Purposes of In Vitro Bioequivalence Testing in the Case of a Nasal Spray Product."

A spray pattern (SP) test is one of the most challenging in vitro tests for nasal spray products (NSPs) associated with a high degree of variation. The total results variation observed in such studies should be in major part representative of product performance to assure high confidence when making conclusions based on obtained results. Analytical methods should be developed in a way to minimize variation contribution of random factors. A systematic statistical assessment of sources of variation is encouraged to be performed during any method development.


Journal Details

This article was published in the following journal.

Name: Journal of aerosol medicine and pulmonary drug delivery
ISSN: 1941-2703


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