Harish Kaushik
☆    

India,
2014-09-12 09:40
(3485 d 08:42 ago)

Posting: # 13491
Views: 2,105
 

 Bortezomib drug class for bioequivalence study [Regulatives / Guidelines]

Hello HS,
I wonder under which class (Biosimilar/Drug), Bortezomib drug falls if somone has to carry out bioequivalence study

Regards
Kaushik
Dr_Dan
★★  

Germany,
2014-09-12 10:20
(3485 d 08:02 ago)

@ Harish Kaushik
Posting: # 13492
Views: 1,760
 

 Bortezomib drug class for bioequivalence study

Dear Kaushik
As far as I know the only reference product on the market is Velcade, a medicine that contains the active substance bortezomib in vials (1 and 3.5 mg) as a powder to be made up into a solution for injection. For injected solutions you do not need a bioequivalence study.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
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