Advances in quality control of inhalable aerosols based on technical requirements of regulation agencies worldwide
Inhalation aerosol is a complex drug-device combination product which is utilized extensively for various respiratory conditions.The availability of inhalable aerosols is limited in both domestic and international markets.There are some discrepancies in the quality control technical requirements of regulation agencies in different countries that hindered the efficient conduct of safety,efficacy and quality control in vitro.The article compared the technical requirements established by regulation agencies through literature research,reviewed the quality control research,and briefly analyzed the existing problems and challenges to provide reference for the research and development of inhalable aerosols.
inhalable aerosolquality controltechnical requirementaerodynamic particle size distribution
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