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Registerbioequivalence of drug combination [Regulatives / Guidelines]
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]
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:
- bioequivalence of drug combination Norah 2018-04-02 12:29 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- bioequivalence of drug combination Beholder 2018-04-09 09:04
- bioequivalence of drug combination Norah 2018-04-10 15:26
- bioequivalence of drug combinationbalakotu 2018-04-13 06:40
- bioequivalence of drug combination Beholder 2018-04-09 09:04
Ing. Helmut Schütz