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RegisterEMA: Q&A Update [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2013-11-15 14:53 (4192 d 23:26 ago) – Posting: # 11890
Views: 14,874
Dear all,
yesterday EMA’s PK working party published Rev. 8 of the Q&A document.
New topics covered are:
yesterday EMA’s PK working party published Rev. 8 of the Q&A document.
New topics covered are:
- Bioequivalence studies for generic application of omega 3 fatty acid ethylesters in a soft gelatine capsule.
- Acceptability of an “additional strengths biowaiver” when bioequivalence to the reference product has been established with a BCS-based biowaiver.
- Question on a generic application for Quetiapine Lambda 200, 300, 400 mg prolonged release tablets.
- BCS classification of memantine.
—
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
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:
- EMA: Q&A UpdateHelmut 2013-11-15 13:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: Q&A Update luvblooms 2013-11-16 06:36
- The early bird gets the worm Helmut 2013-11-16 12:20
- The early bird gets the worm but luvblooms 2013-11-16 14:23
- Lambda Therapeutic Ltd.? Helmut 2013-11-16 15:25
- Lambda Therapeutic Ltd.? luvblooms 2013-11-16 19:24
- Lambda Therapeutic Ltd.? Helmut 2013-11-16 15:25
- The early bird gets the worm but luvblooms 2013-11-16 14:23
- The early bird gets the worm Helmut 2013-11-16 12:20
- EMA: Q&A Update; Expected studies for Quetiapine PR Tablets viveksraut 2018-08-06 14:42
- EMA: Q&A Update luvblooms 2013-11-16 06:36
Ing. Helmut Schütz