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Register…as well as the solubility [Dissolution / BCS / IVIVC]
Dear Mauricio
No, solubility depends on the physico-chemical properties of the API and These can be different between the test and the reference formulation.
Kind regards
Dr_Dan
No, solubility depends on the physico-chemical properties of the API and These can be different between the test and the reference formulation.
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-08 20:38 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
- Biowaiver for Capecitabine - FDA x EMA Mauricio Sampaio 2015-09-09 18:42
- …as well as the solubilityDr_Dan 2015-09-10 08:52
- …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
- regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
- regulatory authorities have a different view Mauricio Sampaio 2015-09-17 06:44
- regulatory authorities have a different view Dr_Dan 2015-09-15 08:53
- …as well as the solubility Mauricio Sampaio 2015-09-15 06:56
- Biowaiver for Capecitabine - FDA x EMA Dr_Dan 2015-09-09 09:00
Ing. Helmut Schütz