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A-M-R ☆ Egypt, 2013-12-19 11:16 (4569 d 11:13 ago) Posting: # 12076 Views: 6,529 |
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Request Atenolol is BCS class III and Chlorthalidone is BCS class IV in fixed dose combination, please inform me if it is necessary to conduct bioequivalence study for both or request for biowaver of Atenolol and bioequivalence study for chlorthalidone Many thanks Amr Hussein Edit: Category changed. [Dr_Dan] |
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Dr_Dan ★★ Germany, 2013-12-19 12:08 (4569 d 10:21 ago) @ A-M-R Posting: # 12077 Views: 5,390 |
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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 — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz