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RegisterFDA enforcing QbD from 2013 [Dissolution / BCS / IVIVC]
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?
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?
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- FDA enforcing QbD from 2013ElMaestro 2012-01-19 15:19
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA enforcing QbD from 2013 Helmut 2012-01-19 15:48
Ing. Helmut Schütz