No prediction of BE from dissolution [Dissolution / BCS / IVIVC]
Dear Helmut,
dear all
I totally understand Srinivasu. From the point of view of a generic company it is very frustrating to see that comparable dissolution does not mean bioequivalence between test and reference. In case of a high soluble drug with a good bioavailability there should be no problem but in other cases we can not predict the outcome. Therefore we try to find some in vitro test which would make the in vivo testing more predictable. I would like if all participants in this forum could share their experience and I am looking forward to your replies.
Kind regards
Dan
dear all
I totally understand Srinivasu. From the point of view of a generic company it is very frustrating to see that comparable dissolution does not mean bioequivalence between test and reference. In case of a high soluble drug with a good bioavailability there should be no problem but in other cases we can not predict the outcome. Therefore we try to find some in vitro test which would make the in vivo testing more predictable. I would like if all participants in this forum could share their experience and I am looking forward to your replies.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Based on Vitro dissolution study in multi pH srinivasu 2010-06-12 11:53
- IVIVC Helmut 2010-06-12 12:32
- IVIVC srinivasu 2010-06-12 12:53
- No prediction of BE from dissolution Helmut 2010-06-12 16:04
- No prediction of BE from dissolutionDr_Dan 2010-06-14 09:30
- About desire Helmut 2010-06-15 12:43
- About desire Dr_Dan 2010-06-15 16:02
- About desire ElMaestro 2010-06-17 00:03
- About desire Helmut 2010-06-15 12:43
- No prediction of BE from dissolutionDr_Dan 2010-06-14 09:30
- No prediction of BE from dissolution Helmut 2010-06-12 16:04
- IVIVC srinivasu 2010-06-12 12:53
- IVIVC Helmut 2010-06-12 12:32
