Decrease in PSD: Need to repeat BE? [Study As­sess­ment]

posted by qualityassurance – 2024-07-02 10:32 (15 d 16:24 ago) – Posting: # 24052
Views: 873

Dear Forum members,

We have conducted a BE study with test product having PSD of X micron API. Now due to patent issue we want to decrease PSD of API to Y micron. Test product is BCS class 3 molecule.
Do we need to conduct BE study again due to change in PSD of API? Our target submission is EMA.

Regards,
QA

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