Bioequivalence and Bioavailability Forum 13:10 CET

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Reference drug pro­duct for Captopril / Hydrochlorothiazide [Design Issues]

posted by A-M-R - Egypt, 2018-10-17 14:46  - Posting: # 19461
Views: 188

Can i use Captopril/Hydrochlorothiazide in concentration of 50/25 (product of Mylan Co.) as reference drug product for bioequivalence study as my generic product in the same concentration taking into consideration that the reference listed drug according to FDA orange book is Captopril/Hydrochlorothiazide in concentration of 25/25 and 50/15 mg tablets( product of Mylan Co.)
very thanks


Edit: Category changed; see also this post #1. Please follow the Forum’s Policy [Helmut]

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