Log in
RegisterBE waiver for tablet after reducing % of API [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2009-05-19 17:25 (6238 d 08:55 ago) – Posting: # 3707
Views: 7,104
Dear Gary,
remember that both the manufacturing process and the analytical method are subjected to some variability. If you have demonstrated BE to the innovator already in vivo, I don't get the point of reformulating. Can you give us a rationale?
remember that both the manufacturing process and the analytical method are subjected to some variability. If you have demonstrated BE to the innovator already in vivo, I don't get the point of reformulating. Can you give us a rationale?
—
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:
- BE waiver for tablet after reducing % of API g.sharma 2009-05-19 14:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE waiver for tablet after reducing % of APIHelmut 2009-05-19 15:25
- BE waiver for tablet after reducing % of API g.sharma 2009-05-19 16:59
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 19:29
- BE waiver for tablet after reducing % of API g.sharma 2009-05-20 09:55
- BE waiver for tablet after reducing % of API Helmut 2009-05-19 19:29
- BE waiver for tablet after reducing % of API g.sharma 2009-05-19 16:59
- BE waiver for tablet after reducing % of APIHelmut 2009-05-19 15:25
Ing. Helmut Schütz