Dissolution Testing Requirement - ANDA [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2019-10-30 03:29 (1631 d 13:58 ago) – Posting: # 20732
Views: 1,925

Guys and gals,

Appreciate your input on this...
For ANDA comparative (T vs R) dissolution testings (Method as per BE guidance + release testing):
1) Do we need to do all the testings on all 3 batches?
2) If not, which testing requires for all 3 batches?

Reason I asked is because my old RA group said comp disso tests (Guidance reqt + release testing) should be done on all 3 batches. But my new RA group said only release test is required on all 3 batches.

Thx
J

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