Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-13 14:36 (2673 d 05:08 ago) – Posting: # 18529
Views: 2,492

Hi Priyal,

❝ Is it must to have matching dissolution profile of all 3 registration batches with RLD for ANDA filing purpose?


Please do your homework first (see also this post #3).
Hint: In vivo equivalence always overrules in vitro similarity.

❝ If 2 batches have F2 50+ but one below 50, then what?


What do you think?

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,684 registered users;
97 visitors (0 registered, 97 guests [including 19 identified bots]).
Forum time: 20:44 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