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Hi, Helmut!
Thx a lot for clarification.
Im just comparing the EU legislation and EEU legislation because it is very similar. May be you or other members of the forum know how can one understand whether we need to perform BEQ study in case of changes in amount of tablets in production batch or not? I refer to the table B.II.b.4 Change in the batch size (including batch size ranges) of the finished product which says (point c):
c) The change requires assessment of the comparability of a biological/immunological medicinal product or the change in batch size requires a new bioequivalence study
(my emphasis)
❝ We find nice numbers which are “easy to remember” everywhere.
Thx a lot for clarification.
Im just comparing the EU legislation and EEU legislation because it is very similar. May be you or other members of the forum know how can one understand whether we need to perform BEQ study in case of changes in amount of tablets in production batch or not? I refer to the table B.II.b.4 Change in the batch size (including batch size ranges) of the finished product which says (point c):
c) The change requires assessment of the comparability of a biological/immunological medicinal product or the change in batch size requires a new bioequivalence study
(my emphasis)
—
Best regards
Beholder
Best regards
Beholder
Complete thread:
- FDA: Size of bio-batch Helmut 2013-12-10 14:05 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: Size of bio-batch jag009 2013-12-10 20:03
- FDA: antique of ’93 Helmut 2013-12-10 23:32
- FDA: antique of ’93 jag009 2013-12-11 15:23
- FDA: antique of ’93 Helmut 2013-12-11 15:26
- FDA: antique of ’93 jag009 2013-12-11 16:21
- FDA: antique of ’93 Helmut 2013-12-11 16:29
- FDA: antique of ’93 jag009 2013-12-11 23:16
- Patience Helmut 2013-12-12 14:34
- FDA: antique of ’93 jag009 2013-12-11 23:16
- FDA: antique of ’93 Helmut 2013-12-11 16:29
- FDA: antique of ’93 jag009 2013-12-11 16:21
- FDA: antique of ’93 Helmut 2013-12-11 15:26
- FDA: antique of ’93 Beholder 2018-06-21 09:21
- Nice numbers Helmut 2018-06-21 15:05
- Nice numbersBeholder 2018-06-22 10:33
- Type II variation Helmut 2018-06-22 15:12
- Nice numbersBeholder 2018-06-22 10:33
- Birdsong's third law of BE ElMaestro 2018-06-22 10:10
- Experience Beholder 2018-06-22 11:04
- Why, oh why? Helmut 2018-06-22 15:17
- Sorry for the delay Beholder 2018-10-18 09:40
- Why, oh why? Helmut 2018-06-22 15:17
- Experience Beholder 2018-06-22 11:04
- Nice numbers Helmut 2018-06-21 15:05
- FDA: antique of ’93 jag009 2013-12-11 15:23
- FDA: antique of ’93 Helmut 2013-12-10 23:32
- FDA: Size of bio-batch jag009 2013-12-10 20:03
Ing. Helmut Schütz