Characterizing Nasal Spray Suspensions for Regulatory and Scientific Purposes

 
웹세미나
규정 및 과학적 목적을 위한
Nasal Spary 특성화 분석
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Why Watch?
Learn about approaches to assessing bioequivalence for complex generics including:

Assessing API particle size changes within the formulation,
Assessing interactions between the formulation and device.

Demonstrating bioequivalence (BE) for complex generics such as nasal spray suspension drug products is a challenging task. Sponsors not only have to consider device requirements but also understand the properties of the API in the presence of functional excipients. The process of achieving equivalence to the reference listed drug product is therefore complex. In this presentation we explore the requirements for BE and the application of in vitro techniques for API and formulation characteristics. 

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