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PriyalAayushi
Junior

India,
2018-03-13 04:09

Posting: # 18524
Views: 995
 

 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
Hero
avatar
Homepage
Vienna, Austria,
2018-03-13 13:36

@ PriyalAayushi
Posting: # 18529
Views: 797
 

 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?

Cheers,
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. ☼
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jag009
Hero

NJ,
2018-03-15 21:45

@ PriyalAayushi
Posting: # 18557
Views: 666
 

 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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