Mithu
★    

India,
2023-05-04 06:59
(148 d 22:01 ago)

Posting: # 23541
Views: 921
 

 505 b(2) application & requirement of bio­equi­va­lence [Regulatives / Guidelines]

Hello All,


My question is, "is it mandatory to have 505b(2) application bio-equivalent to current reference listed drug?"

regards,

Mithu
dshah
★★  

India/United Kingdom,
2023-05-05 15:38
(147 d 13:22 ago)

@ Mithu
Posting: # 23545
Views: 724
 

 505 b(2) application & requirement of bioequivalence

Hello Mithu!

As we rely on existing PKPD relationship, toxicity data and other pharmacology data of reference drug, the BE is required.

Regards,
Divyen
Mithu
★    

India,
2023-05-11 09:58
(141 d 19:02 ago)

@ dshah
Posting: # 23548
Views: 642
 

 505 b(2) application & requirement of bioequivalence

Hi Divyen,

Thank you for your reply.

regards,

Mithu
Achievwin
★    

US,
2023-05-05 18:08
(147 d 10:52 ago)

@ Mithu
Posting: # 23546
Views: 751
 

 505 b(2) application & requirement of bio­equi­va­lence

Hello Mithu:

505 (b)(2) is all about the submission and marketing strategy. Most of the 505(b)(2) applications take BE route as drug Chemistry, safety and efficacy along with biopharmaceutics is already known and BE is used as a knowledge (claim) gap bridging approach. There are other means you can get 505(b)(2. Please review different guidance (FDA, EMA etc.) or white papers on 505(b)(2).

Hope this helps
Mithu
★    

India,
2023-05-11 09:58
(141 d 19:02 ago)

@ Achievwin
Posting: # 23549
Views: 625
 

 505 b(2) application & requirement of bio­equi­va­lence

Hello Achievwin,

Thank you for your reply.

regards,

Mithu
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