PriyalAayushi
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India,
2018-03-13 05:09
(2228 d 22:15 ago)

Posting: # 18524
Views: 2,325
 

 Profile comparison requirements [Regulatives / Guidelines]

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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
(2228 d 12:48 ago)

@ PriyalAayushi
Posting: # 18529
Views: 1,892
 

 Homework

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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
(2226 d 04:39 ago)

@ PriyalAayushi
Posting: # 18557
Views: 1,777
 

 Profile comparison requirements

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❝ 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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