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Egypt,
2013-12-19 11:16
(4574 d 19:21 ago)

Posting: # 12076
Views: 6,568
 

 Atenolol/Chlorthalidone [Regulatives / Guidelines]

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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]
 
Dr_Dan
★★  

Germany,
2013-12-19 12:08
(4574 d 18:29 ago)

@ A-M-R
Posting: # 12077
Views: 5,417
 

 Atenolol/Chlorthalidone

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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
 
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