Log in
Registerbiowaiver for Simvastatin suspension [Dissolution / BCS / IVIVC]
Dear PJS
Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption (BCS class I&III). As you already stated above simvastatin is no highly soluble drug (BCS class II with a high intra-subject variability). Only if an active substance is considered highly soluble, it is reasonable to expect that it will not cause any bioavailability problems. In case of simvastatin you will not be able to determine the formulation effect unless you have performed a BE study.
Kind regards
Dr_Dan
Applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption (BCS class I&III). As you already stated above simvastatin is no highly soluble drug (BCS class II with a high intra-subject variability). Only if an active substance is considered highly soluble, it is reasonable to expect that it will not cause any bioavailability problems. In case of simvastatin you will not be able to determine the formulation effect unless you have performed a BE study.
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 Simvastatin suspension pjs 2015-04-23 11:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- biowaiver for Simvastatin suspension pjs 2015-05-15 14:55
- biowaiver for Simvastatin suspensionDr_Dan 2015-05-18 09:58
- biowaiver for Simvastatin suspension pjs 2015-05-18 15:31
- biowaiver for Simvastatin suspension nobody 2015-05-18 16:23
- biowaiver for Simvastatin suspension pjs 2015-05-18 15:31
Ing. Helmut Schütz