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IPAC-RS welcomes opportunities to address topics of mutual interest collaboratively with other organizations.  For example, the following three specific initiatives were addressed through the Product Quality Research Institute:

Strategies for control of leachables and extractables in orally inhaled and nasal drug products

Role of cascade impaction mass balance

Characterization of the chi-square ratio test for in-vitro equivalence determinations

In collaboration with USP, IPAC-RS developed recommendations for microbiological testing of orally inhaled and nasal drug products

Through ISO, IPAC-RS in collaboration with EPAG is engaged in the development of international standards for inhalers and nebulizers. 

A Quality-by-Design (QbD) approach to analytical methods development and registration is being discussed with a PhRMA analytical technical group.

 

EPAG

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