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ElMaestro ★★★ Denmark, 2012-01-19 16:19 (5257 d 21:40 ago) Posting: # 7965 Views: 5,521 |
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Hi all, I note that FDA has been moving lately in the area of QbD and they seem to be mandating QbD from 2013 for ANDAs / 505(j)'s. Here's a presentation. They have even published an example on how it could be done for an MR generic. I just skimmed through it and I think it is very, very extensive. If this example is in anyway representative of the amount of typically needed from an applicant/developer then I think US development is going to be a lot more expensive in the future. What's your take on this? — Pass or fail! ElMaestro |
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Helmut ★★★   Vienna, Austria, 2012-01-19 16:48 (5257 d 21:11 ago) @ ElMaestro Posting: # 7966 Views: 4,511 |
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Dear ElMaestro! ❝ 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 ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz