2019-10-30 02:29
(1023 d 19:35 ago)

Posting: # 20732
Views: 1,525

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

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.

UA Flag
 Admin contact
22,305 posts in 4,668 threads, 1,587 registered users;
online 8 (0 registered, 8 guests [including 5 identified bots]).
Forum time: Thursday 23:04 CEST (Europe/Vienna)

On two occasions I have been asked,—“Pray, Mr. Babbage,
if you put into the machine wrong figures,…
will the right answers come out?”
I am not able rightly to apprehend the kind of confusion of ideas
that could provoke such a question.    Charles Babbage

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz