Log in
RegisterBE or biowaiver ? [Regulatives / Guidelines]
Dear Debbie,
If your submission is intended for the EU market, why not try a biowaiver ? I would say most, if not all, EU Member States would accept a dossier without a BE for aspirin. Or is it a modified release formulation you are dealing with ?
Regards
Ohlbe
If your submission is intended for the EU market, why not try a biowaiver ? I would say most, if not all, EU Member States would accept a dossier without a BE for aspirin. Or is it a modified release formulation you are dealing with ?
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Bioequivalence study of Aspirin Debbie 2011-01-31 16:38
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence study of Aspirin ElMaestro 2011-01-31 16:59
- BE or biowaiver ?Ohlbe 2011-01-31 23:34
- BE or biowaiver ? Debbie 2011-02-01 16:36
- BE or biowaiver ? manan 2011-02-02 07:06
- BE or biowaiver ? Debbie 2011-02-01 16:36
Ing. Helmut Schütz