jag009 ★★★ NJ, 2019-10-30 03:29 (1634 d 01:20 ago) Posting: # 20732 Views: 1,931 |
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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 |