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posted by Helmut 
– Vienna, Austria, 2018-03-13 14:36 (1914 d 01:33 ago) – Posting: # 18529
Views: 1,747
Hi Priyal,
Please do your homework first (see also this post #3).
Hint: In vivo equivalence always overrules in vitro similarity.
What do you think?
❝ 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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Profile comparison requirements PriyalAayushi 2018-03-13 04:09 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- HomeworkHelmut 2018-03-13 13:36
- Profile comparison requirements jag009 2018-03-15 21:45
Ing. Helmut Schütz