jag009
★★★

NJ,
2019-10-30 03:29
(2077 d 13:37 ago)

Posting: # 20732
Views: 2,745
 

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

Post reply
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
 
UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,681 registered users;
81 visitors (0 registered, 81 guests [including 16 identified bots]).
Forum time: 18:06 CEST (Europe/Vienna)

No matter what side of the argument you are on,
you always find people on your side
that you wish were on the other.    Thomas Berger

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