Harish Kaushik
☆    

India,
2014-09-12 09:40
(3507 d 11:11 ago)

Posting: # 13491
Views: 2,148
 

 Bortezomib drug class for bioequivalence study [Regulatives / Guidelines]

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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
(3507 d 10:31 ago)

@ Harish Kaushik
Posting: # 13492
Views: 1,796
 

 Bortezomib drug class for bioequivalence study

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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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