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RegisterFDA enforcing QbD from 2013 [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2012-01-19 16:48 (5266 d 19:05 ago) – Posting: # 7966
Views: 4,523
Dear ElMaestro!
Ooh–ooh! We discussed the draft already last year. Saw one presentation by a representative of the FDA last year (forgot where…) – seemed to be very serious about “That’s the way to go!”.
Would be tough to meet these requirements. Could FDA really reject an ANDA if BE was demonstrated in vivo, similar dissolution (f2), and an established IVIVC if the development was not done according to their interpretation (sic!) of Section 2.1 of ICH Q8(R2)? Any lawyers around?
❝ What's your take on this?
Ooh–ooh! We discussed the draft already last year. Saw one presentation by a representative of the FDA last year (forgot where…) – seemed to be very serious about “That’s the way to go!”.
Would be tough to meet these requirements. Could FDA really reject an ANDA if BE was demonstrated in vivo, similar dissolution (f2), and an established IVIVC if the development was not done according to their interpretation (sic!) of Section 2.1 of ICH Q8(R2)? Any lawyers around?
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
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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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:
- FDA enforcing QbD from 2013 ElMaestro 2012-01-19 15:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA enforcing QbD from 2013Helmut 2012-01-19 15:48
Ing. Helmut Schütz