2018-10-17 12:46
(968 d 23:20 ago)

Posting: # 19461
Views: 1,410

 Reference drug pro­duct for Captopril / Hydrochlorothiazide [Design Issues]

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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