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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: 314

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]

Complete thread:

Reference drug product for Captopril / Hydrochlorothiazide - A-M-R, 2018-10-17 14:46 [Design Issues]

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Bioequivalence and Bioavailability Forum 04:02 CET

Reference drug pro­duct for Captopril / Hydrochlorothiazide [Design Issues]

Complete thread:

Reference drug product for Captopril / Hydrochlorothiazide [Design Issues]