Dissolution Calibration ASTM Vs USP

My question is for Mr. Ken and the community (if you're confident in your answer): Regarding the ASTM Enhanced Mechanical Calibration for Dissolution apparatus, while the USFDA clearly recommends this method as an alternative to the traditional USP PVT in their guidance, I haven't found any mention of it in other regulatory bodies' guidance. What is the stance of other regulatory bodies, such as those in the EU and Canada? Is it acceptable to adopt this method as an alternative to the USP method?

Was this helpful?