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RegisterType II Variation [Regulatives / Guidelines]
Hi Helmut,
Thank you for your reply. This really helps.
We are still in developing phase and consider the size of the biobatch.
Just to be sure, if the biobatch is < 100,000 units and the scale-up is up to 10 fold, a type II Variation is needed, supported by a Bioequivalence study?
Kind regards,
Elena
Thank you for your reply. This really helps.
We are still in developing phase and consider the size of the biobatch.
Just to be sure, if the biobatch is < 100,000 units and the scale-up is up to 10 fold, a type II Variation is needed, supported by a Bioequivalence study?
Kind regards,
Elena
Complete thread:
- biobatch size and scale up Elena 2013-09-17 10:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Type II Variation Helmut 2013-09-17 16:36
- Type II VariationElena 2013-09-18 08:42
- Type II Variation Dr_Dan 2013-09-18 10:01
- Type II Variation Ohlbe 2013-09-18 12:41
- Type II Variation Elena 2013-09-18 12:55
- Type II Variation Dr_Dan 2013-09-18 10:01
- Type II VariationElena 2013-09-18 08:42
- Type II Variation Helmut 2013-09-17 16:36
Ing. Helmut Schütz