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RegisterAtenolol/Chlorthalidone [Regulatives / Guidelines]
Dear Amr Hussein
Do you have a fixed dose combination? If yes then it will not be possible to perform an in-vitro biowaver for Atenolol and demonstrate bioequivalence for chlorthalidone by means of an in-vivo study. Both components of the drug product need to be evaluated regarding their bioavailability in one and the same comperative bioavailability study.
If you are talking about two different products then you can request for biowaver of Atenolol and perform a bioequivalence study for chlorthalidone.
I hope this helps
Kind regards
Dan
Do you have a fixed dose combination? If yes then it will not be possible to perform an in-vitro biowaver for Atenolol and demonstrate bioequivalence for chlorthalidone by means of an in-vivo study. Both components of the drug product need to be evaluated regarding their bioavailability in one and the same comperative bioavailability study.
If you are talking about two different products then you can request for biowaver of Atenolol and perform a bioequivalence study for chlorthalidone.
I hope this helps
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Atenolol/Chlorthalidone A-M-R 2013-12-19 10:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Atenolol/ChlorthalidoneDr_Dan 2013-12-19 11:08
Ing. Helmut Schütz