2. Guidance for Extractable Study on Packaging System of Inhalation Aerosols(Draft for Comments)参考资料说明.pdfVIP
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- 2024-08-08 发布于北京
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GuidanceforExtractableStudyon
PackagingSystemofInhalationAerosols
(DraftforComments)
Introduction
Aninhalationdrugcombinesthecharacteristicsofinhaled
formulationsandaerosols,whileinteractionbetweenthedrug
formulationandpackagingsystembearsthehighestlevelof
risk.Inhaledaerosoldrugformulationsaremainlybasedonorganic
mediaphase,andthepackagingsystemhasacomplicatedstructure,
involvingplastics,rubber,metalandothermaterials.Thesefactors
determinethatinhalationaerosolpackagingsystemanddrug
compatibi
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