PriyalAayushi
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India,
2018-03-13 05:09
(2292 d 19:16 ago)

Posting: # 18524
Views: 2,509
 

 Profile comparison requirements [Regulatives / Guidelines]

Dear friends,

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

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

Please help.

Thanks
Helmut
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Vienna, Austria,
2018-03-13 14:36
(2292 d 09:49 ago)

@ PriyalAayushi
Posting: # 18529
Views: 2,040
 

 Homework

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?

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jag009
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NJ,
2018-03-15 22:45
(2290 d 01:40 ago)

@ PriyalAayushi
Posting: # 18557
Views: 1,923
 

 Profile comparison requirements

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


1) For FDA?
2) I assume F2 comparisons among all 3 batches are >50?

J
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