Homework [Regulatives / Guidelines]
» 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?
The quality of responses received is directly proportional to the quality of the question asked. ☼