Log in
RegisterReplicate design(s): why not? [Regulatives / Guidelines]
Dear HS and Other members
Regards
Yes!!
This is what gave us hope!
Besides there was a paper published in 2003 Discussion Paper
Bioequivalence Requirements: Highly Variable Drugs and Highly Variable Drug Products: Issues and Options where they have discussed about SABE and RABE. But they didn't fail to mention that THESE PAPERS ARE INTENDED ONLY FOR DISCUSSION AT THE WORKSHOP AND EAC-BB MEETING ON JUNE 26-27, 2003
We are planning to submit the study with an ammendment in protocol!!
Lets see!!
Will update to the forum if anything interesting comes up!!
Besides
There was one more observation in one of the study for Canada Market
Out of 72 volunteer 2 showed 0 absorption for reference!!!
Looks like buggers
threw the formulations away!!
Though the study is passing with and without those volunteers and we have decided to submit the same to the Health Canada.
But I would like to ask that in such condition, how one should handle it?
Any suggestion??
Thanks in advance!!
Luv
Regards
❝ Why not? Reading in between
Yes!!
This is what gave us hope!
Besides there was a paper published in 2003 Discussion Paper
Bioequivalence Requirements: Highly Variable Drugs and Highly Variable Drug Products: Issues and Options where they have discussed about SABE and RABE. But they didn't fail to mention that THESE PAPERS ARE INTENDED ONLY FOR DISCUSSION AT THE WORKSHOP AND EAC-BB MEETING ON JUNE 26-27, 2003
We are planning to submit the study with an ammendment in protocol!!
Lets see!!
Will update to the forum if anything interesting comes up!!
Besides
There was one more observation in one of the study for Canada Market
Out of 72 volunteer 2 showed 0 absorption for reference!!!
Looks like buggers
threw the formulations away!!Though the study is passing with and without those volunteers and we have decided to submit the same to the Health Canada.
But I would like to ask that in such condition, how one should handle it?
Any suggestion??
Thanks in advance!!
Luv
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Health Canada Submission: full replicate BE study allowed? luvblooms 2011-04-01 14:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate design(s): why not? Helmut 2011-04-01 16:15
- Replicate design(s): why not?luvblooms 2011-04-05 08:54
- Replicate design(s): why not? ElMaestro 2011-04-05 10:05
- Replicate design(s): why not? luvblooms 2011-04-05 13:58
- No concentration after reference product Ohlbe 2011-04-05 10:30
- Replicate design(s): why not? ElMaestro 2011-04-05 10:05
- Replicate design(s): why not?luvblooms 2011-04-05 08:54
- Replicate design(s): why not? Helmut 2011-04-01 16:15
Ing. Helmut Schütz