Ramesh Ramalingam
☆    

India,
2017-09-20 13:43
(2403 d 10:59 ago)

Posting: # 17820
Views: 3,144
 

 Bioequivalence study under Korea submission [Regulatives / Guidelines]

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Dear All,

Can we conduct a bioequivalence study in INDIA for KOREA Submission?

Let me know, If you know korea regulatory requirements for conducting BABE study.



Regards,
Ramesh.R
 
wienui
★    

Germany/Oman,
2017-09-21 00:19
(2403 d 00:22 ago)

@ Ramesh Ramalingam
Posting: # 17822
Views: 2,663
 

 Bioequivalence study under Korea submission

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❝ Let me know, If you know korea regulatory requirements for conducting BABE study.


Hi Ramesh,
This could be helpful,
https://www.omicsonline.org/an-overview-on-bioequivalence-regulatory-consideration-for-generic-drug-products-jbb.1000037.php?aid=652
regards,
Osama
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Cheers,
Osama
 
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