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Back to the forum  2018-06-22 02:08 CEST (UTC+2h)
Norah
Junior

Tunisia,
2018-04-02 12:29

Posting: # 18630
Views: 933
 

 bioequivalence of drug combination [Regulatives / Guidelines]

Hello
I need your advice please regarding this :
if ever a drug combination (like candesartan hydrochlorothiazide) has demonstrated its BE with the princeps,
is it mandatory to perform study for candasertan alone (same pharmaceutical company, same dosage)

Thanks !
Beholder
Regular

Russia,
2018-04-09 09:04

@ Norah
Posting: # 18655
Views: 491
 

 bioequivalence of drug combination

Hi, Norah!

» (same pharmaceutical company, same dosage)

What about excipients? The same quality and quantity?

Best regards
Beholder
Norah
Junior

Tunisia,
2018-04-10 15:26

@ Beholder
Posting: # 18661
Views: 409
 

 bioequivalence of drug combination

Hello Beholder
Yes all is the same
balakotu
Regular

India,
2018-04-13 06:40
(edited by Ohlbe on 2018-04-13 10:22)

@ Norah
Posting: # 18675
Views: 322
 

 bioequivalence of drug combination

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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