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Back to the forum  2018-07-23 00:10 CEST (UTC+2h)

bioequivalence of drug combination [Regulatives / Guidelines]

posted by balakotu - India, 2018-04-13 06:40  - Posting: # 18675
Views: 368

(edited by Ohlbe on 2018-04-13 10:22)

Hello Norah,
As per USFDA, it is mandatory to perform separate studies for separate products.
FDA will not accept plain candesartan ANDA without BE studies.
Moreover, candesartan a BCS class II product and waiver approach (based on combination product BE study) is not possible to get the waiver for plain Candesartan.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

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