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Dear Manan!
Jaime, not Jamie.
Of course, that's the idea. For an example plasma profile see here.
!
What about this one?
There are no specific guidelines. Why do you think there should be one? An osmotic pump is just a biopharmaceutical technology and therefore within the scope of modified release guidelines.
❝ Dear Jamie
Jaime, not Jamie.
❝ [...] However, as the cocept used here is osmotic pressure, i hope there will be some changes in the PK profile of the formulation.
Of course, that's the idea. For an example plasma profile see here.
❝ Do we have any guidline in place for OROS formaultion?
❝ can you please let me know in detail about the OROS formulation?
!What about this one?
❝ i searched FDA and EMEA guidances but i wasnt able to find it.
There are no specific guidelines. Why do you think there should be one? An osmotic pump is just a biopharmaceutical technology and therefore within the scope of modified release guidelines.
—
Regards, Jaime
Regards, Jaime
Complete thread:
- Future of Generic markets manan 2010-12-17 06:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Patent protection Helmut 2010-12-17 14:10
- Future of Generic markets Phaneendra.K 2010-12-28 15:49
- Patent Jaime_R 2010-12-28 16:05
- OROS manan 2010-12-29 05:49
- OROSJaime_R 2010-12-29 15:30
- OROS manan 2010-12-30 07:29
- OROS Jaime_R 2010-12-30 14:12
- Uploading literature Helmut 2011-01-01 15:25
- OROS manan 2010-12-30 07:29
- OROSJaime_R 2010-12-29 15:30
- OROS manan 2010-12-29 05:49
- Patent Jaime_R 2010-12-28 16:05
- Future of Generic markets ElMaestro 2010-12-29 22:40
Ing. Helmut Schütz