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

posted by jag009  – NJ, 2019-10-30 02:29 (641 d 00:39 ago) – Posting: # 20732
Views: 1,145

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

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 6 (0 registered, 6 guests [including 2 identified bots]).
Forum time: Sunday 04:08 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5