Publications by authors named "Simon M Berger"
Article Synopsis
- The FDA looks at different types of studies to make sure nasal sprays work the same way for people.
- This study compared two versions of a nasal spray with different particle sizes to see how quickly they work in the body.
- The results showed that the smaller particles dissolved faster and were better at getting the medicine into the system than the larger particles.
The aim of this study was to further evaluate and optimize the Transwell system for assessing the dissolution behavior of orally inhaled drug products (OIDPs), using fluticasone propionate as a model drug. Sample preparation involved the collection of a relevant inhalable dose fraction through an anatomical mouth/throat model, resulting in a more uniform presentation of drug particles during the subsequent dissolution test. The method differed from previously published procedures by (1) using a 0.
View Article and Find Full Text PDFIn the context of streamlining generic approval, this study assessed whether pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products (OIDPs). Three fluticasone propionate (FP) dry powder inhaler (DPI) formulations (A-4.5, B-3.
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