Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-04-25 00:47 UTC (UTC+2h)
 

bioequivalence of drug combination [Regulatives / Guidelines]

posted by balakotu - India, 2018-04-13 04:40  - Posting: # 18675
Views: 148

(edited by Ohlbe on 2018-04-13 08:22)

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]

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
18,208 posts in 3,871 threads, 1,154 registered users;
26 users online (0 registered, 26 guests).

Mediocrity finds safety in standardization.    Frederick E. Crane

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed