F1 and F2 values and dissolution profile [Dissolution / BCS / IVIVC]
Dear Jayesh
How do you know that the US reference product has the same formulation as the European reference product? You will never know! I also tried once but the agencies did not accept the argument US RLD = EU RLD although there was worlwide only one production site and the qualitative composition was the same. A single 3WC study using RLD from USA and EU bears the risk that one comparison fails. The consequence would be that you present unfavourable data to the agency. In case when everything is fine nobody would ask, in case of failure you have to find strong arguments how you selected your reference batches. This might lead to endless discussions. I strongly recommend to perform two studies, one for the US market and one for Europe.
O.K. I agree that it is more expensive but you are on the safe side.
Kind regards
Dan
How do you know that the US reference product has the same formulation as the European reference product? You will never know! I also tried once but the agencies did not accept the argument US RLD = EU RLD although there was worlwide only one production site and the qualitative composition was the same. A single 3WC study using RLD from USA and EU bears the risk that one comparison fails. The consequence would be that you present unfavourable data to the agency. In case when everything is fine nobody would ask, in case of failure you have to find strong arguments how you selected your reference batches. This might lead to endless discussions. I strongly recommend to perform two studies, one for the US market and one for Europe.
O.K. I agree that it is more expensive but you are on the safe side.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- F1 and F2 values and dissolution profile govardhanpillari 2009-03-04 12:30 [Dissolution / BCS / IVIVC]
- F1 and F2 values and dissolution profile drcampos 2009-03-04 13:51
- F1 and F2 values and dissolution profile Aceto81 2009-03-05 12:30
- F1 and F2 values and dissolution profile Helmut 2009-03-05 14:01
- F1 and F2 values and dissolution profile govardhanpillari 2009-03-06 06:04
- F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
- F1 and F2 values and dissolution profile govardhanpillari 2009-03-07 05:47
- F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
- US RLD / European reference Helmut 2009-03-05 14:15
- European reference Ohlbe 2009-03-05 19:09
- F1 and F2 values and dissolution profile jayeshd 2010-04-17 08:58
- EU + US Ohlbe 2010-04-17 20:19
- F1 and F2 values and dissolution profileDr_Dan 2010-04-19 14:51