Norah
★    

Tunisia,
2018-04-02 14:29
(2186 d 21:49 ago)

Posting: # 18630
Views: 2,559
 

 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
★    

Russia,
2018-04-09 11:04
(2180 d 01:15 ago)

@ Norah
Posting: # 18655
Views: 1,770
 

 bioequivalence of drug combination

Hi, Norah!

❝ (same pharmaceutical company, same dosage)


What about excipients? The same quality and quantity?

Best regards
Beholder
Norah
★    

Tunisia,
2018-04-10 17:26
(2178 d 18:52 ago)

@ Beholder
Posting: # 18661
Views: 1,735
 

 bioequivalence of drug combination

Hello Beholder
Yes all is the same
balakotu
★    

India,
2018-04-13 08:40
(2176 d 03:39 ago)

(edited by Ohlbe on 2018-04-13 10:22)
@ Norah
Posting: # 18675
Views: 1,672
 

 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]
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
71 visitors (0 registered, 71 guests [including 6 identified bots]).
Forum time: 11:19 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5